Regulatory Specialist Resume Samples

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Regulatory Specialists are in charge for licensing and marketing pharmaceutical and medical products to ensure their safety and efficacy. Specific responsibilities of a Regulatory Specialist are complying with legislation in the field, assessing scientific data, handling license renewals, assessing scientific data, coordinating teams of colleagues, and making presentations to regulatory authorities. Based on our collection of resume samples, the most sought-after skills in the field are analytical thinking, problem solving, strong communication abilities, being able to work to strict deadlines, negotiation, and knowledge of relevant legislation. Employers choose resumes displaying a degree in biochemistry or another life science.

For more information on what it takes to be a Regulatory Specialist, check out our complete Regulatory Specialist Job Description.

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1

Regulatory Specialist

Responsible for EU/USA specifications with EU/USA labeling data flavors and finished food concepts, EU/USA MSDS, allergen data, natural status, TTB, Kosher certificates, Halal reviews and finished products labeling and nutritional data. Main contact for all patent pending technology and the completion of documentation for all high end value customers.

  • Maintained finished goods data/labels in SAP system for all plant sites (neat chemicals and finished flavors), entered and maintained MSDS documents/allergen data and updated nutrition information.
  • Provided standard and customer specific documents for key customer accounts and researched the issues surrounding the legislative status of formulae.
  • Decreased document turnaround time on new formula requests by streamlining the request process and implementing request assignment and completion policy.
  • Participated in site-specific weekly early warning meetings, reported on vendor issues and secured agreement with specialty chemical site on the status of EU Natural raw materials.
  • Championed [company name] position on topics regarding allergens, bioengineered ingredients, organic status, generally recognized as safe, and Natural.
  • Assisted in the successful transfer of one manufacturing site from manual to SAP ERP system.
Candidate Info
8
years in
workforce
6
years
at this job
BA
Liberal Arts
BS
Biological Sciences
MA
Business Administration
2

Collection Operations Support Associate/regulatory Specialist

Regulatory Specialist tasks included managing the maintenance and organization of over 300 pieces of equipment necessary for daily blood drives; including performing and thoroughly reviewing yearly, monthly, and weekly preventative maintenance work orders in accordance with current good manufacturing practices. It was also crucial to work closely with drive supervisors, account managers, staff, and equipment specialists to ensure that the eight teams and fixed site had enough functioning equipment to successfully complete a blood drive.

  • Eliminated time and organizational issues at secured collection sites by implementing a system to ensure the correct equipment was documented and sent with staff.
  • Performed thorough review of work orders completed by staff to identify and correct errors that may have compromised patient safety, produced problems, and/or incurred a fine from the FDA.
  • Completed time sensitive preventative maintenance work orders on time to ensure equipment was in date, functioning properly, and 100% compliant with FDA and AABB regulations.
  • Facilitated efficiency of non-routine maintenance for equipment by contacting vendors and scheduling maintenance activities, assessing and performing small repairs to save the company money, sending units to and receiving units from the equipment management group, and redistributing equipment to teams in a timely manner.
  • Provided support to staff performing weekly download activities by troubleshooting computer issues, coordinating communication with regional IT services, and performing download activities for absent staff and computers back from repair.
Candidate Info
8
years in
workforce
2
years
at this job
BS
Biology
3

Regulatory Specialist

  • Responsible for cost development and rate design for wholesale operations and retail cooperatives.
  • Prepared wholesale cost study and testimony as a professional witness in state revenue requirement proceedings.
  • Managed rate cases, including the disposition of interrogatories and the preparation of depositions.
  • Assisted in the development of the rate designs for 11 retail electric cooperatives.
  • Developed and implemented training for retail electric cooperatives on cost and rate design.
  • Responsible for state compliance filings and reporting.
Candidate Info
3
years in
workforce
3
years
at this job
MA
Economics
4

Regulatory Specialist/compliance Coordinator

  • Assessed and assured that offenders within the State correctional system receive healthcare as mandated by federal and state law and national standards
  • Coordinated compliance with the Memorandum of Agreement with the Department of Justice including preparing for, participating in and responding to Federal monitor visits, drafting compliance reports for publication and communicating regularly with all involved parties
  • Facilitated efforts to improve operational compliance within the correctional facilities
  • Oversaw vendor's Continuous Quality Improvement Program
Candidate Info
13
years in
workforce
1
year
at this job
BA
Sociology
MS
Healthcare Administration
JD
Law
5

Regulatory Specialist II

  • Analyzed complex data and communicated results verbally and in writing
  • Advised practitioners of most optimal avenues to attain state licensure
  • Maintained position as a Top Three Performer in monthly metrics reports
Candidate Info
8
years in
workforce
1
year
at this job
BS
Interdisciplinary Studies
6

Senior Regulatory Specialist, New York

  • Developed and implemented 10+ investigator initiated trial protocols and 7 single patient Investigational New Drugs (INDs) in the last two years
  • Leading a team of 3 regulatory specialists to activate and manage over 90+ clinical trials in the field of breast, genitourinary (GU) and head & neck oncology sponsored by top 10 global pharmaceutical companies
  • Interface with regulatory authorities and sponsors throughout the clinical trial to ensure compliance to FDA related and Good Clinical Practices (GCP) regulations in conduct of clinical research at the cancer center, affiliated sites and external sub-sites
  • Develop study timelines for rapid activation of clinical trials
  • Training and mentoring new hires and research community on regulatory policies and institutional procedures
Candidate Info
7
years in
workforce
2
years
at this job
BS
Biotechnology
MS
Bioscience Regulatory Affairs
7

Project Manager / Regulatory Specialist

  • Responsible for reviewing labeling and promotional material for FDA compliance program.
  • Presented “what if” scenarios for budget assumptions and forecasting strategies.
  • Budgeted active and proposed projects by accurately determining pricing, margins and risk factors.
  • Reviewed and analyzed project spending throughout project life cycle.
  • Consolidated financial data and materials for key leadership meetings.
  • Implemented a set of comprehensive tracking processes to monitor cost performance.
  • Directed all phases of production projects, from pilot order to commercial orders.
Candidate Info
6
years in
workforce
8
months
at this job
AS
Accounting
BA
International Business Management
8

Regulatory Specialist I

Prepped, scanned, indexed and coded applications into the system once received into the department.

  • Knowledge of License Ease, Microsoft Office & Windows.
  • Reviewed curriculum, transcripts, degrees and other educational materials of applicants having received educational training.
  • Operated photocopying machines, typewriters, calculator, mailroom machinery, computer terminals, microfilm and microfiche readers and related equipment with such accuracy as can be acquired on the job and other related duties assigned.
  • Responsible for answering incoming and conducting outbound calls to new and existing customers regarding business license.
Candidate Info
23
years in
workforce
5
years
at this job
9

Regulatory Specialist III

  • Approved import permits for biologics and Class IIa & IIb medical device products following FDA, USDA, CBP and CDC regulations.
  • Resolved master data issues to create multiple master project lists for the department.
  • Organized and filed documents following Abbott’s corporate document retention policy.
Candidate Info
3
years in
workforce
6
months
at this job
BS
Biology And Psychology
10

Regulatory Specialist

Study Start-up and IRB submissions

  • Assisted clinic manager in budget negotiations
  • Set-up and maintained regulatory files performing regular internal audits
  • Maintained and prepared documents for submission to Contract Research Organizations and regulatory agencies
  • Acted as point of contact for CROs and sponsors
  • Active in site selection and initiation process
  • Created study specific source documents
  • Conducted study visits
  • Resolved queries within various data entry programs
  • Collected and processed samples.
Candidate Info
12
years in
workforce
2
years
at this job
BS
Business Administration
Clinical Research

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