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0-5 years of experience
Pharmaceutical lab exclusively dedicated to animal health. Develops, produces and distributes drugs and vaccines for the prevention and treatment of the pathologies in companion and food producing animals.
- Coordinated and followed up on regulatory actions.
- Collaborated with internal working groups for packaging creation of newly acquired products; reviewed and validated product information in packaging, instructions for use, and labels.
- Addressed and responded to questions from regulatory agencies.
- Prepared applications for variations to regulatory agencies.
0-5 years of experience
Responded to deficiencies and questions related to DMFs and Annual Report submissions.
- Coordinated with other team members for developing and implementation of the SOP
- Examine and compile the Labeling, Advertising and Promotional materials with Regulatory Compliance
- Reviewed and approved quality system documents to determine compliance with regulatory regulations and standards
0-5 years of experience
- Designated as a Lead Quality Auditor for internal audits system
- Administered and configured SAP and MasterControl business solutions
- Assisted Regulatory and Quality departments in maintaining QMS
- Developed SOPs, policies, and process documentation
- Maintained data gathering and mining efforts for Production, Quality, and other functions
0-5 years of experience
Assisted in preparing clinical trial submissions for various INDs.
- Maintained up-to-date knowledge of data requirements and formats, applicable current SOPs,
- Reviewed revised product labeling information, package inserts, and container/packaging
- Identified and composed draft correspondence relevant to projects as assigned, such as letters of response, transmittal and memoranda where applicable.
- Maintained, scanned, and imported documents into regulatory documentum system.
0-5 years of experience
Prepared and maintain SOPs and training records.
- Performed Design of Experiment, Process Capability Study, Accuracy and Precision, Statistical Process Control and Gage R&R for optimization of various process parameters using Minitab16 statistical software.
- Prepared Failure Mode Effect Analysis (FMEA) sheets and performed risk assessment.
- Performed Process Development studies, CAPA and Root Cause Analysis.
- Authored Validation Master Plan, Process/Cleaning Validation Protocols, Equipment Qualification Protocols and Validation Summary Reports.
- Executed IQ, OQ and PQ protocols for equipment at lab scale.
6-10 years of experience
Served as Lead Administrator of a Regulatory Submission Management System and Repository.
Managed a "system-dedicated" mailbox that encompasses processing over 1500 access accounts and user records to meet internal compliance standards.
- Provided valuable feedback on system enhancements and processes to lead improvement efforts.
- Trained 170 global business partners and colleagues on new global Regulatory Submission Management System and Repository to ensure team's compliance to corporate policies.
- Assisted Regulatory liaisons with the preparation, publishing and electronic filing of Regulatory submissions such as New Drug Applications (NDA), Investigational New Drug Applications (IND), consumer and professional advertising to meet FDA compliance deadlines.
- Oversaw system support help desk to ensure user ticket issues are resolved in a timely fashion and comply with the company's Service Level Agreement (SLA).
0-5 years of experience
- Implemented the first corporate regulatory eCTD submission software system and subsequent upgrades,
- Trained all Regulatory Affairs personnel on the use of eCTD software, electronic publishing, use of the [company name] gateway, and SPL conversions,
- Represented Regulatory Affairs on other corporate GMP software implementation teams,
- Supervised the conversion of legacy paper files to electronic files,
- Prepared and submitted Original Submissions, Amendments, Periodic Adverse Drug Experience Reports, Annual Reports, Supplements, SPL/Drug Listings, and Establishment Registrations.
0-5 years of experience
Provided submission development support to project teams and the regulatory community with product/projects assigned to RA Ops submission staff across divisions based on business need.
- Supported the compilation, development, publishing, submission and maintenance of regulatory filings under the direction of RA Ops submission manager and Regulatory Affairs associates. Thorough knowledge of regulatory filing, of IND, NDA, ANDA, BLA.
- Managed the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using Electronic Document Management System, to ensure that said documents meet requirements for Submission.
- Liaison with local internal departments and Corporate RA and QA to obtain documentation required for registrations or other regulatory submissions. Supported on major applications in an effort to support submission timelines and Completion of assigned tasks with a high level of quality within company timelines.
- Became Aware of ICH and FDA regulations and guidance as we applied to electronic submissions and also became Familiar with content and organization of regulatory submissions. Followed company standard operating procedures and policies.
- Assisted in maintenance of product information and planning milestones for global regulatory activities. Prepared and published of regulatory submissions including preparation, QC, tracking and archiving.
- Supported the compilation of submission outlines and assembly of submissions assuring accurate recordkeeping and documentation preparation. Assisted in all areas of responsibility, including interpreting and enforcing paper and electronic regulatory submission standards, policies and operating procedure requirements.
6-10 years of experience
SharePoint administrator for Regulatory Affairs. Development and maintenance of all websites under the Regulatory Affairs organization. Technical and end-user support of the collaboration environment used within Regulatory Affairs.
- Provided first-line support of the eRoom collaboration environment, reviewed all new eRoom requests, created new eRooms when approved, and worked with IT to create external eRooms.
- Developed and maintained all Regulatory Affairs intranet websites using IBM WebSphere and Web Content Management software.
- Worked closely with IT to migrate the collaboration environment (eRoom) and websites (WebSphere) to the SharePoint platform, ensuring all migrations were successful and end-users were supported.
0-5 years of experience
Conduct international market research for pharmaceutical trading worldwide
- Set a regulatory strategy for international trading of surgical equipment, insulin, and syringes
- Performed initial physical assessment on patients in eye clinic
- Completed rigorous training in mechanism, presentation, triage, and management of common overdoses and toxins
- Received and managed calls with attention to emotional state and education level of caller
0-5 years of experience
Reviewed and evaluated labeling for product packaging as per the regulatory requirements
- Proofread container and cartons labels, patient leaflets and medication guides
- Evaluated submission packages of APIs for their accuracy and regulatory compliance
- Documented Annual Report submissions
0-5 years of experience
Prepared new and existing ANDA submissions.
- Imported PI and Labels in Daily Med using HL7 A4L SPL system.
- Performed compliance check on documentation for electronic submission.
- Managed all aspects of regulatory process including annual reports and amendments.
- Submitted six Initial INDs for the treatment of chronic lymphocytic leukemia (CLL), Schizophrenia, Autism Spectrum Disorder and Acute myelogenous leukemia (AML), Multiple Sclerosis and Alzheimer Disease.
- Recognized with certificate of excellence by global regulatory head
- Certified in InSight Publisher
- Created various submission process improvement projects
- Transitioned numerous paper submissions in eCTD format
0-5 years of experience
Maintained regulatory documents and changes controls (Change Request) from manufacturer sites on spreadsheet to track updates in product specifications and materials.
- Reviewed data from Trackwise, GxPharma and Oracle databases and converted information in eCTD format to send electronic submission to the FDA.
- Complied and submitted the following regulatory documents in eCTD format to the FDA: CBE-30 drug substance and drug product method updates; CBE-0 changes to packaging configurations, CBE-0 updates to Master Batch Records, Minor and Telephone Amendments in response to FDA questions.
- Managed annual report documents from international manufacturer sites for inclusion in Commercial Product Annual Reports.
- Reviewed Safety Alert Reports, Field Alerts, Deviation Reports and Stability Reports initiated by the Quality Assurance department for legal compliance
0-5 years of experience
Provided production support for electronic and paper publishing activities of business critical regulatory documents and dossiers, including but not limited to, Initial IND and NDA filings, IND and NDA Annual Reports, New Protocols and Protocol Amendments, Chemistry, Pharm/Tox and Clinical Amendments, IND Safety Reports, Labeling, Efficacy, CMC, CBE(-30) and Prior Approval Supplements, Drug Listing submissions
- Expert Core Dossier and Documentum user ensuring compilation of high quality electronic documents and dossiers for submission to regulatory authorities
- Maintained regulatory files and electronic databases
- Coordinated training on all regulatory work practices and standard operating procedures
- Prepared and submitted 2 major electronic sNDAs within 1 month for company's major anti-diabetes drug
- Prepared and submitted 2 major MAAs in CTD format for company's major cholesterol lowering drug
- Coordinated the production of the numerous INDs and NDAs of major products for due diligence activities
- Accurately and efficiently created and processed regulatory safety reports (Adverse Events and Serious Adverse Events) within the company's electronic Corporate Adverse Event Reporting and Evaluation System/database
- Functioned as the liaison between the Regulatory Safety and Biostatistics and Data Management teams
- Utilized Regulatory Safety work practices, standard operating procedures and teamwork to increase productivity and morale
0-5 years of experience
Preparation of draft Container and Carton Label, Package Insert
- Proofread of packaging labels and inserts for drug products
- Work closely with Graphics Department which included proofreading labels before delivering format and content as well as proofreading final product from Graphics Department before sending to manufacturing sites Supported CTD and e-CTD Module Compilation (SBS PI+, Dissolution data preparation, Graphical data preparation, and prepared relevant tables for all original ANDA submitting)
- Labeling Activities such as Original Submission, Supplements, Amendments, SPL, PLR, and Commercial Package Insert
- Prepared and Compiled CTD Modules (Module 1, Module 2.7, Module 3.2.P.1, 3, 5, 6 and 8, and Module 3.2.R)
- Supplement Filing (prepared and complied the PAS for Alternative source of API)
- Received Industrial Training at [company name].
- Assisted to perform quantitative and qualitative analyses of raw material, in process products and finished products following standard operating procedures, using various analytical instrument such as high performance liquid chromatography, gas chromatography, analytical balances, infrared instruments, dissolution testing apparatus.
- Assisted in calibration of lab instruments and evaluation of test results for accuracy.
- Performed standardization of solutions and various instruments as required and recorded results in official logs.
- In-depth knowledge regarding production of solid and liquid dosage form in compliance cGMP guidelines.
0-5 years of experience
Gather, extrapolate and interpret data to accurately complete regulatory statements, including but not limited to Safety Data Sheets, Specification Sheets, Nutritional Statements, GMO Statements.
- Evaluate flavor and fragrance formulations for compliance to a host of regulations and guidelines.
- Manage information on raw materials to guarantee current and precise data.
- Cooperate with Sales Staff, Customer Service, and clientele to provide prompt and exact documentation.
- Synchronize with other departments to maintain organization of formulas and flow of information.
- Instruct new employees on computer software, lab equipment, and standard operating procedures.
- Review and rectify documents created by Laboratory Technicians.
0-5 years of experience
Prepare and submit 510(k)s and documents to file
- Prepare and submit PMA Supplements
- Contribute to IDE submissions
- Interface with regulatory agencies regarding regulatory submissions and compliance
- Review promotional copy for regulatory compliance
- Review/approve all changes (e.g., label, IFU, device design) after assessing for regulatory impact
0-5 years of experience
Executed plans to ensure all trials were conducted in compliance with the study protocol, site procedures, GCP guidelines, and applicable regulatory requirements.
- Managed all aspects of the clinical development program through strategic planning to effectively achieve program goals; ensured that the design, conduct, and generation of data was supportive of regulatory applications resulting in several new drug approvals and new indication approvals. Activities included, development and management of protocols, contracts and agreements, case report forms and informed consent forms; clinical site selection, site visits, education of other health care professionals, monitor for accuracy and completeness, data collection, analysis, processing/management of adverse event reports, query resolution, and close-out visits.
- Prepared, reviewed, and maintained regulatory documents and submissions to FDA; i.e. annual reports, amendments, Abbreviated New Drug Applications ("ANDA's"), [company name], New Drug Application ("NDA") submissions, FDA responses, drug Establishment registrations, drug listing, Division of Drug Marketing, Advertising and Communications ("DDMAC") reports, briefing documents (IND/NDA), adverse events safety reports.
- Managed the development and approval of labeling.
0-5 years of experience
- Selected to be in the 1st pilot group for training in the new MIDAS TMF application due to being detail-oriented and a top producer
- Administered the preparation and participated in several FDA audits and inspections
- Served as an integral member of a clinical trial team for several current Phase I-III studies
- Was a direct participant for the reconciliation and processing of data within the GPV Safety project
- Maintained regulatory documentation trackers for any and all outstanding issues and processing
- Managed activation, initiation and closeout of studies and sites in all phases of clinical trials
- Ensure consistent analysis, classification, registration and disposition of trial essential documents within the TMF to allow for their consistent tracking and inspection.
- Monitor/track appropriate documentation to meet contracted and agreed upon SR timelines
- Responsible for processing metrics, errors, returns and delays for department as per SLA requirements
- Therapeutic Area: Antithrombotic (Cardiovascular), Antitumor Agents (Oncology), Diabetes,
0-5 years of experience
- Research and development of a high profile project within the company (510(k) Compliance and Nationals Project)
- Investigate and record change histories of Medical Devices that aid in the review and completion of the 510(k) submission process
- Utilize proficient knowledge of Microsoft Office, Adobe, CAD & PCRP by producing spreadsheets, presentations, and documentation for regulatory projects
- Compile information from various company databases (ShareDrive, SharePoint & Baxter Project Lifecycle Management)
- Organize 510(k) product code information into easily accessible data collection files
0-5 years of experience
Verifies that documentation is complete and meets submission readiness standards.
- Responsible for quality of documentation entered into electronic systems and for the quality of submissions.
- Supports the compilation of regulatory submissions and documentation packages through departmental policies and procedures including some document initiation.
- Responsible for enforcement of submission readiness standards.
- Collaborate with authoring community to identify and introduce best practices for document preparation..
0-5 years of experience
Assist in developing procedures to ensure regulatory compliance with domestic and global requirements.
- Support Global Regulatory Operations (GRO) and the Global Regulatory Lead (GRL) to identify and communicate a list of country requirements.
- Manage information related to an EVMPD (EudraVigilance Medicinal Product Dictionary) Project and other project activities on an ad hoc basis.
- Update databases related to product registration.
- Create and maintain guidance documents for various projects associated with pharmacovigilance.
0-5 years of experience
Associate for Consumer Affairs Special Services; handling highly escalated situations such as consumers who have hired legal counsel, filed complaints with attorney generals and other
government regulatory agencies, compensation requests and irate individuals.
- Began in position within Operations support and through demonstration of ability to learn
- Working majority of the time with little to no supervisory assistance.
- Assisting in training of new agents and acting as a resource to other agents within the call
- Consistently achieved high quality while processing consumer files.
- Going above and beyond by assisting colleagues with their work after they had moved on to separate projects.
- Communicated with litigious consumers, government regulatory representatives,
- Commended for outstanding customer service and set as an example for other agents how to demonstrate excellence.
0-5 years of experience
- Planning, management, collaboration, authoring and compilation of applications (emphasis on CMC related documentation) for submission to the FDA (including original applications, amendments, supplements and annual reports for NDAs, ANDAs, INDs and DMFs)
- Review labeling associated with filed applications
- Chairperson of Computer Validation Task Force to address 21 CFR Part 11 related issues
- License registrations with state Boards of Pharmacy
- Review of process or product changes to evaluate impact on filed applications and determine filings required for changes
0-5 years of experience
Assisted the Sr. Director level position in assuring the timely preparation and submission of all regulatory documentation. Personally responsible for the following specific tasks:
- Initial review against check list template all clinical development/regulatory documents for completeness and consistency prior to Sr. Director level review, including new protocols, amendments, informed consent forms, clinical study reports, and standard operating procedures (SOPs).
- Preparation of covers letters and forms (e.g. Form FDA 1571) for all types of regulatory submissions.
- Review and Approve Drug Shipment request packet.
- Accurate preparation, compilation and publication of all regulatory submissions supporting the clinical development program, including protocols, information amendments, safety reports etc., in strict adherence to the regulatory guidelines and against tight deadlines.
- Electronic file management and version control in Documentum.
- Accurate filing and maintenance of Global Regulatory Files, contacts and correspondence to / from global regulatory authorities.
- Management of an internal Regulatory Affairs Database for all global registrations, contacts and correspondence.
- Managed, organized and maintained a user-friendly Regulatory Affairs submission room, including preparations for a FDA pre-approval inspection.
- Training of new staff on departmental processes.
0-5 years of experience
Responsible for reviewing Annual reports, ANDAs, Supplements, Certificates of Analysis, Batch records, Labeling- container labels and Patient inserts for accuracy and completeness.
- Extensive experience navigating and retrieving clinical/regulatory documents utilizing documentum.
- Point person for written submissions and liaison with the FDA (federal and local) to ensure that regulatory submissions have been received.
- Receives calls from consumer's, healthcare professionals and pharmacists regarding adverse events and product complaints.
- Responsible for completing Medwatch forms, creating annual and periodic reports and compiling documents to be submitted for ANDAs.
0-5 years of experience
- Prepare regulatory (ANDA) documents for submission to FDA authorities using e-CTD submission gateway
- Prepare regulatory documents for all modules of the ANDA and deficiency responses, specifically labeling and module 3
- Maintain awareness of and expertise in ICH, FDA and EU guidelines related to CMC regulatory topics
- Collect data and prepare documents for submission to FDA
- Remain current with federal and international regulations, and communicate that information within the organization, including creating training materials
- Create and set up a sequence for a new or existing application and add the necessary documents (forms, correspondence, reports, data files, etc.) to the sequence Table of Contents and Hyperlinks
- Provide the sequence to the designated reviewers, publish and sequence to the file system and validate the sequence and correct any technical errors and release of sequence to a regulatory authority (FDA)
0-5 years of experience
- Compile and analyze research for creation of substantiation files for ingredients/products.
- Ensure labeling, website and marketing pieces are compliant under FTC/FDA guidelines for dietary supplements and that they are adequately substantiated.
- Facilitate and coordinate the implementation of the company's regulatory strategy throughout all departments.
- Keeping abreast of new rules/regulations/warning letters/ingredient trends.
- Train Customer Service Representatives in regulatory compliant product information for new and existing products.
- Answer technical/formulation customer questions with compliant responses.
0-5 years of experience
Manage and establish regulatory submission filing system
- Gain knowledge and understanding of IND/NDA submission processes
- Support Global Regulatory Team on documentation needs
- Use of e-team rooms and PLM systems to retrieve information
- Support and participate in e-CTD process as needed
- Lead and direct consultants on specific needs of regulatory filing process
0-5 years of experience
Publish, compile and submit regulatory non-eCTD electronic submissions (NeeS) and FDA Electronic
Submission Gateway (ESG) submissions, including Investigational New Drug (IND) and New Drug
Application (NDA) original submissions, amendments, supplements, meeting requests, annual
reports and safety reports
- Prepare and submit IND protocol amendments for new clinical investigators
- Prepare and submit NDA Prior Approval Supplements for prescribing information
- Prepare and submit advertising and promotional materials for the Office of Prescription Drug
- Coordinate with Commercial Affairs to submit drug sample accountability reports in accordance with
- Maintain drug establishment registration and drug product listings for commercial products
- Maintain ClinicalTrials.gov for new and ongoing clinical trials including registering protocols and submitting results
- Maintain electronic Trial Master Files for clinical studies
- Manage state pharmaceutical distribution licenses
0-5 years of experience
- Assist in evaluating results from pharmacology, pharmacokinetic, and toxicology studies on drug candidates, both novel chemical entities (NCE) and macromolecules, being developed to treat various diseases, such as cancer, pain, diabetes.
- Review and edit study reports to ensure that the information in the reports followed the study protocol (and where appropriate, were in compliance with Good Laboratory Practice [GLP] Regulations), that the results were completely and effectively reported and discussed, and that the conclusions appropriately described and summarized the generated results.
- Prepare and review summaries of study reports and publications to be included in the nonclinical sections of INDs and NDAs (both in Common Technical Document [CTD] format).
6-10 years of experience
- Reviewed and approved clinical product labels and directions for use and US commercial
- Prepared IND annual report and competitive advertising complaints for submission to FDA;
- Monitored FDA labeling & promotion news; edited an internal labeling & promotion newsletter; contributed to regulatory position papers and a textbook chapter; precepted student interns
0-5 years of experience
- Complied dossier documents for INDs, ANDAs for accuracy and adequacy which included SOP’s, Exhibit batch documents, Amendments, Notifications and reports, R&D documents and other related documents.
- Reviewed Drug Master Files (DMFs), Annual Product Quality Reports (APQRs) and submitted response to federal agency.
- Compiled dossiers in CTD format for submission to federal agency specifically for Drug Product Sections
- Reviewed Analytical Method Validation/Method Verification as per ICH Guidelines Q2A,Q2B and Q6A
- Assessed change controls and prepared submissions arising from the change control process.
- Reviewed documents including labeling drafts and stability protocols and reports
- Provided regulatory guidance to Manufacturing, Validation, Quality Control, Quality Assurance, Supply and Logistics.
0-5 years of experience
Project lead for development of client's compliance data system used to track regulatory submissions, maintain CMC information, and support regulatory operations and change management for investigational and post-approval products.
- Supporting regulatory maintenance and managing product dossier compliance investigations of regulatory applications such as NDAs, CTAs, IDEs, INDs, ANDAs, 510Ks, BLAs, and MAAs.
- Responsible for data analysis, legacy system migration, quality assurance, and process alignment of compliance data systems and change management processes. Ensuring that data standards within CMC align with standards of Health Authorities to meet market-specific regulatory requirements.
- Developing standardized forms and user guides in order to maintain effective communication for collaborating groups and providing training and guidance to client's strategists and team members as needed.
- Ensuring client business development is in accordance with domestic and international legislation, guidelines, and industry practices.
- Conducting weekly team meetings to provide project progress updates to sponsor and personnel.
0-5 years of experience
Represent Regulatory team on the scientific exchange materials review team and provide guidance on regulatory issue related to scientific exchange.
- Assist in the development and cross functional review of labeling such as USPI, SmPC, Core Data Sheet, and SPL
- Review, approve and archive advertising and promotional materials for oncology product
- Lead the FDA OPDP submission for advertising and promotion material for oncology product
- Perform regulatory research to support regulatory strategy for labeling and promotional claims
- Lead the process harmonization activities for Ad/Promo team
- Assist in registration activities for NDA/BLA submission of oncology drug products
- Assist in the development of SOP and job aids to streamline the process for Labeling and Promotion team
- Manage regulatory documents in document management system and SharePoint site
0-5 years of experience
Prepared CMC registration and re-registration dossiers, MAA, and File A for marketed Oncology products.
- Interacted with Worldwide Regulatory affiliates and Ministries of Health regarding technical and clinical questions, along with providing all pertinent Certificates required for Approval or Change Control needs.
- Interacted with Clinical, Marketing, and Life Cycle Management for filing strategies.
- Interfaced with BMS manufacturing sites for technical specifications, test methods, stability data, and database related issues for registration in foreign markets.
0-5 years of experience
Ensure product related CMC regulatory filings are prepared and implemented in accordance with global regulatory strategies, regulations and commercialization strategies.
- Provide supports to the global regulatory representative by performing appropriate product support activities including: Document coordination and archival.
- Assist in development of regional and global regulatory strategies.
- Develop and maintain departmental processes ensuring that these processes are aligned with company requirements.
- Develop and maintain regulatory knowledge through meetings, conference and departmental interactions.
- Participates in the development and maintenance of policies, SOP's and associated documents to support global regulatory.
- Participates in meeting with regulatory authorities, interact also with Operations, Process Development and RA-CMC senior staff to develop appropriate US and global regulatory filing strategies.
- Responsibilities include providing support for maintaining and filing post approval supplements, CBEs and comparability protocols for marketed products.
0-5 years of experience
- Preparation of Supplements, Annual Reports and responses to FDA review letters/request for additional information in eCTD format in support of existing products
- Preparation of ANDA's in eCTD format in support of new products
- Actively participate in the Company's project management system and submission compilation team meetings providing Regulatory guidance to Development Teams, Technical Services and Operations
- Retrieve, review, and collate all supporting documentation for FDA submissions
- Prepare submissions on project management basis and carry projects through to FDA approval
- Review batch records, master formula, validation protocol, and validation report for accuracy and regulatory acceptability
- Communicate with Internal key Departments such as Product and Analytical Development, Technical Services, Operations, and Quality Assurance
0-5 years of experience
Support development projects, new submissions and approved applications
- Attend project meetings, provide regulatory assistance to team members
- Assist in coordinating submission activities to the FDA
- Provide technical expertise in submission software with electronic files and databases
- Assist in development, retention and maintenance of regulatory application files
- Execute research assignments and provide summaries
- Maintain, assist in reviewing and record retention of Bioequivalence documents
- Prepare and submit to the FDA annual reports for approved application products
- Prepare and submit to the FDA periodic adverse event reports
0-5 years of experience
- Participation in the development of regulatory strategies
- Prepare, author and submit regulatory submissions (PMA panel track, PMA180-Day, 30-Day Notice, supplements, Annual Report, and CE Mark Technical File)
- Create, revise, review and approve documents through change order process
- Represent Regulatory Affairs on various cross-functional teams: design control, document control, Material Review Board (MRB), complaints, corrections and removals, Corrective and Preventive Action (CAPA) Board, and future product core teams
- Perform internal audits as the lead auditor to assure company compliance to FDA, MDD, CMDR, ISO regulations and internal policy
- Assist in external regulatory body audits (FDA, NB, etc)
- Serve as the MRB coordinator and perform Oracle inventory transactions
- Facilitate MRB meetings to discuss nonconforming material and MRB disposition decisions
- Reporting: Medical Device Reports (MDRs) and EU vigilance Reports
- Strong knowledge of Code of Federal Regulations Title 21 and ISO 13485:2003
0-5 years of experience
Work on the EVMPD (EudraVigilance Medicinal Product Dictionary) Project
- Prepare, review and verify product registrations for domestic and international approved products
- Project Leader for GRL (Global Regulatory Lead) submission development team, which provides the global regulatory community with product registrations and submissions across divisions based on business needs
- Participate and provide required deliverables to the development team as an internal regulatory team member and FDA liaison throughout the product development cycle
0-5 years of experience
- Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations.
- Plans and organizes registration packages. Prepares registration packages in line with local and international regulatory requirements and guidelines.
- Evaluates manufacturing for regulatory impact with guidance. Accurately describes these changes for ease of regulatory agency review.
- Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions.
0-5 years of experience
Submit and review documents for ANDAs, NDAs and Annual Reports.
- Coordinate and process documents for registration.
- Write and revise SOP's related to regulatory documents.
- Generate and coordinate documents for ANDA submissions.
- Review and submit advertisements / promotional materials to the FDA.
- Respond to deficiencies applications, amendments and supplements for new and existing products for FDA. Review changes proposed to OTC and Rx labeling, labeling manufacturing process, test methods, and specifications. Prepare labeling side-by-side comparison.
- Coordinate recall and effectiveness checks. Develop, revise, approve, and documentation control Akorn product labeling for regulatory submissions and for retain and promotional release.
- Interface with QA/QC/R&D, Marketing and Manufacturing. Effectively balance and prioritize the scheduling of submission projects and tasks.
- Maintain the regulatory database files are accurate and current. Participation on products reviews and evaluates project priorities.
0-5 years of experience
Assist management with coordination and preparation of document packages for regulatory submissions from all areas of company, in support of active and pending New Drug Applications (NDAs) (e.g. annual reports, supplements, adverse event reporting, labeling, FDA submission forms and advertising/promotion).
- Apply knowledge of regulatory requirements to the review of scientific documentation intended for submission to regulatory authorities to ensure compliance with FDA.
- Responsible for complaints processing and filing adverse event reports.
- Perform routine functions of diversified scope with moderate supervision; Write/review department SOPS as needed; Write, proofread and check documents for accuracy; Relate information to requirements and ability to identify inconsistencies; Keep abreast of regulatory procedures and changes.
6-10 years of experience
- Develop new product labeling for developmental compounds and maintain Company Core Data Sheets (CCDSs), Unites States Package Inserts (USPIs) and Summary of Product Characteristics (SmPCs) for therapeutic area products worldwide
- Assess and resolve prescription drug labeling issues, taking into account global regulatory requirements and strategies
- Strategically collaborate with pharmacovigilance, clinical and medical staff, legal, marketing and other regulatory affairs personnel to resolve global labeling issues
- Liaise with Periodic Safety Update Report (PSUR) group to manage the risk benefit profiles for Abbott products worldwide
- Drive the labeling subteam process to provide responses to deficiency letters and label change requests, generate clinical overview addenda and support clarification requests for regulatory agencies worldwide
0-5 years of experience
- Represent Regulatory Affairs on cross functional new product development teams
- Assess regulatory impact of product modifications, manufacturing changes, additional international markets
- Review and approval of promotional literature as well as product labeling for both domestic and international markets with varying level of regulatory requirements
- Responsible for maintenance of international design dossiers and essential requirements checklists
- Responsible for both domestic and international establishment registrations and listings of devices and tissue based products
- Development of submission strategies for varying classes of devices and HCT/P products
- Developed the regulatory SOPs to manage Investigational Device Exemption (IDE) submissions and regulatory assessment process
- Developed and maintain a comprehensive system for analyzing publically available regulatory documentation for competitive products
0-5 years of experience
- Manage Regulatory Labeling documents in Documentum based system FirstDoc.
- Conducts regulatory research for labeling related activities for drugs under development.
- Conducts approval to print and archive branded and non-branded promotional and advertising materials
- Collaborates with Regulatory Operations in the preparation of OPDP submission for promotional materials
- Assist in registration activities for oncology drug products
- Assist in the QC review of labeling such as USPI, SmPC, CCDS, and SPL.
- Business Lead for the implementation of DocuProof system for proofreading labels.
- Writing job aids to increase to streamline the process for Labeling and Promotion team
- Manage Regulatory Labeling and Promotion team sites and project specific SharePoint sites
- Functional Area Administrator (FAA) for Labeling and Promotion Team to manage Documentum system
0-5 years of experience
- Review all promotional, advertising and labeling materials to ensure compliance with all federal regulations and adherence to company policies.
- Apply Regulatory expertise into the development of brand plans and strategic imperatives.
- Provide regulatory strategy, feedback, and direction to the project team and the global regulatory teams.
- Acquire and maintain knowledge of current regulatory requirements, providing support and guidance throughout the organization to ensure compliance.
- Compile, collate and prepare information/data to be included in Annual Product Reviews.
- Manage Drug Listing function within Regulatory Affairs; prepares, reviews and submit SPL (Structured Product Labeling) to the Agency.
- Assist in the development of labeling for NDA and monograph OTC products
- Ensure optimal labeling on supplemental applications for labeling changes
- Create, review and update SOPs.
- Prepare and file regulatory documents for company products in compliance with internal policies, guidelines, and procedures.
0-5 years of experience
Developed and evaluated prescription drug labeling and promotional literature to ensure compliance with federal regulations, company policies, and industry standards
- Acted as primary liaison and support for special projects on issues relating to new prescription drug regulatory and governmental guidelines and procedures.
- Gained expertise through participation in "Regulatory Affairs and the Healthcare Product Lifecycle" course.
- Interfaced with various corporate divisions including drug safety, regulatory affairs, global label consistency efforts, and legal counsel for document preparation, approvals, and submissions.
- Provided background information for senior review for maintenance of new/current /modified products including the coordination of regulatory and information system activities
- Created, compiled, maintained, and tracked Microsoft Access database to track the review, changes, and approval of key promotional materials.
Compliance Cover Letter Examples
