Regulatory Affairs Specialist Resume Template

Regulatory Specialist Resume Examples

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.

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Regulatory Specialist Duties and Responsibilities

Regulatory specialists perform varying daily duties, depending on the size of the company they work for and the compliance issues that exist within that company. However, there are several universal job tasks that are essential to this career in all business environments:

Assess Protocols Regulatory specialists assess all company protocols for compliance with city, state, and federal laws.

Revise Policies Regulatory specialists analyze company policies, making revisions to these policies where necessary.

Assess Risk Regulatory specialists perform a risk assessment of all company policies and practices.

Audit Company Processes Regulatory specialists audit company processes and protocols to find flaws and fixes.

Write Reports Regulatory specialists write detailed reports on problems found within a company and send these documents to the appropriate government agencies, such as the FDA, FTC, or EPA, when necessary.

Maintain Licensing Regulatory specialists manage company license renewals and registration paperwork to keep companies compliant.

Brief Administrators Regulatory specialists stay up-to-date on regulatory code changes, briefing company administrators and executives on these changes to help them maintain regulatory compliance.

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Regulatory Specialist Skills and Qualifications

Regulatory specialists use analytical skills to assess company policies and monitor all compliance issues, writing risk assessment reports where necessary. Employers seek out regulatory specialists who have the different skills needed to perform their regular job tasks.
  • Analytical ability - regulatory specialists perform assessments and evaluations
  • Communication - regulatory specialists work in a collaborative environment and provide verbal and written reports
  • Attention to detail - because regulatory specialists are responsible for maintaining compliance and staying up-to-date on regulatory policies, employers look for individuals who maintain strong attention to detail to fill this role
  • Time-management - regulatory specialists use time-management skills to prioritize work tasks and meet deadlines
  • Organization - regulatory specialists manage multiple work tasks, file reports, and analyze a lot of data
  • Computer skills - regulatory specialists write reports using software programs and analyze digital files
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Regulatory Specialist Education and Training

Some employers require regulatory specialists to have a bachelor's degree in business management or a related field, but the vast majority of employers accept candidates who have a high school diploma or equivalent in addition to relevant work experience. For some employers, an associate's degree will suffice in place of past work experience. Training is offered to newly-hired regulatory specialists. This training period varies by company and by candidate, depending on how much education and/or experience the candidate has already acquired. During training, regulatory specialists work under the close supervision of a senior regulatory specialist or a compliance manager.
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Regulatory Specialist Salary and Outlook

Detailed job data from the Bureau of Labor Statistics (BLS) show that financial examiners earned a median salary of $81,690 annually and $39.28 hourly in 2017. Financial examiners occupied more than 50,000 jobs in 2016, a number the BLS expects to grow by 10 percent through 2026. This rate is faster than the national job growth average. Like regulatory specialists, financial examiners ensure compliance with laws, review data, and assess company management practices. According to data provided by PayScale, regulatory specialists earn $55,914 median annual income. Typically, regulatory specialists receive full benefits packages from employers that include healthcare insurance with dental and vision insurance. Retirement planning and life insurance are usually included in these benefits packages. Paid holidays, sick days, and vacation days are also provided by employers. Some companies offer additional perks, such as continuing education reimbursement.
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Helpful Resources

Use these resources to find jobs, workplace strategies, information, and career tips for regulatory specialists:

Society of Corporate Compliance and Ethics - This website for professionals in the compliance industry, which includes regulatory specialists, provides job listings, certification program information, upcoming event dates, and resources containing press releases and compliance-related content.

The New Era of Regulatory Enforcement: A Comprehensive Guide for Raising the Bar to Manage Risk - This book was written by experts to provide a framework for regulatory specialists working in the modern world. The text includes information about the challenges regulatory specialists face and how to manage them.

Regulatory Affairs Professionals Society - Find news and articles for regulatory specialists on this website, which also provides event dates, information about training programs, research resources, and job openings.

The Regulatory Craft: Controlling Risks, Solving Problems, and Managing Compliance - This book was written for regulatory specialists to provide information about risk control, solving problems, and how to manage the daily tasks these professionals must perform.

Ethics & Compliance Initiative - Find resources and research information on this website designed for all ethics and compliance professionals, including regulatory specialists.

Regulatory Crisis: Negotiating the Consequences of Risk, Disasters and Crises - Find out how to manage disasters in the regulatory profession with this book that provides tips and strategies for managing problems and risks.

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