How to Become a Regulatory Affairs Specialist

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How to Become a Regulatory Affairs Specialist: Career Path Guide

If you want to become a regulatory affairs specialist, you first need to determine if this career path is a good fit for your skills, interests and personality traits. If the following description sounds like you, then you’re probably well suited for a career as a regulatory affairs specialist:

 

• You have a keen interest in doing detailed work

• You have an interest in working on products that have a mandate to help sick people

• You are willing to write and review documents that can be thousands of pages long

• You enjoy the idea of collaborating with and advising other professionals

• You have an interest in the legislation governing the approval of products

• You have considerable understanding of both legal and scientific matters

 

Below we've outlined what you'll need to begin a career as a regulatory affairs specialist. We've also included helpful information for this career, such as job description, job duties, salary expectations, a list of possible employers and much more!

 

 

Regulatory Affairs Specialist Job Description

A regulatory affairs specialist acts as a link between their employer, its products, and regulatory agencies. Their main objectives are to ensure the safety and efficacy of their company’s pharmaceutical and medical products, and to obtain the necessary licensing to get their products to market.

 

This involves collecting and reviewing marketing, legal, regulatory and licensing documentation, and preparing evidence-based and convincing market applications for submission to regulatory agencies, in order to have their company’s products approved for sale and distribution.

 

The work of a regulatory affairs specialist is very detail-focused, as it involves writing and reviewing documents that can be thousands of pages long.

 

To perform their job effectively, a regulatory affairs specialist must have a wide skill set, one that can take years to develop. They must have an understanding of government language and processes, strong abilities in science, reading comprehension and writing, as well as a strong understanding of legal matters and regulations pertaining to the industry they operate within.

 

 

Regulatory Affairs Specialist Job Duties

• Be involved in all aspects of the application to take the product to market

• Ensure marketing applications are evidence-based and convincing

• Take part in regulatory agency inspections

• Respond to inquiries from regulatory agencies, such as the U.S. Food and Drug Administration 

• Contribute in regulatory forums

• Ensure that regulations are properly communicated through corporate policies and procedures

• Coordinate, prepare and review regulatory submissions for domestic and foreign projects

• Coordinate the efforts related to the preparation of regulatory documents and submissions

• Identify relevant guidance documents and provide interpretive assistance

• Maintain current knowledge of existing as well as emerging regulations, standards and guidance documents

 

 

Education Needed to Become a Regulatory Affairs Specialist

Having a bachelor’s degree in a variety of fields, typically in science, will qualify you for many entry-level jobs in regulatory affairs. To progress to the role of regulatory affairs specialist, you will likely require a great deal of experience in entry-level roles in addition to your bachelor’s degree, or you will require a master’s degree in a life science or health related field.

 

Typically, the more education and related experience you have, the greater your chances of qualifying for jobs with greater responsibility. For example, those in higher-level regulatory affairs positions, such as “Director of Regulatory Operations” tend to have doctoral degrees: a Ph.D., an M.D., or both. 

 

 

 

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Experience Needed to Become a Regulatory Affairs Specialist

To perform their job effectively, a regulatory affairs specialist must have a strong knowledge base and skill set in science, reading comprehension and writing, as well as a strong understanding of legal matters and regulations pertaining to the industry they operate within.

 

This knowledge base and skill set are typically acquired through a combination of experience and education. Typically, the more education you have, the less experience you will need to be hired into a regulatory affairs position, and vice versa. The ideal candidate for most regulatory affairs specialist jobs however, will have plenty of both.

 

Those who become regulatory affairs specialists often gain the necessary experience by working in relevant areas (such as research or quality assurance) within the healthcare, pharmaceutical and medicinal product industry.

 

They may also gain this experience by working in positions such as regulatory coordinator or regulatory associate. These positions are involved in administrative activities, such as information management, project tracking, or general support for market application submission. 

 

 

Who Creates Jobs for Regulatory Affairs Specialists?

Regulatory affairs specialists are typically employed on a full-time or contractual basis by the following types of organizations:

 

• Biotech and pharmaceutical companies

• Companies that manufacture medical devices and diagnostic equipment

• Cosmetics companies

• Companies that produce nutritional products

• Contract research agencies

• Regulatory, legal, marketing and scientific consulting firms

• Healthcare and medicinal product regulatory agencies

 

 

 

Regulatory Affairs Specialist Job Opportunities

Regulatory Affairs Specialist Jobs - Canada

 

Regulatory Affairs Specialist Jobs - United States

 

 

 

Regulatory Affairs Specialist Salary

The salary level of regulatory affairs specialists can vary depending on factors such as:

 

• Their level of education

• Their level of experience and aptitude

• The size and type of their employer

• The region in which they work

 

There is no salary information available from reliable sources specifically for the career Regulatory Affairs Specialist, although we can get a good idea of what they earn by looking at the salary level of workers in related careers fields.

 

Regulatory Affairs Specialist Salary United States: According to the United States Bureau of Labor Statistics, the mean annual wage of American workers in the Compliance Officers occupational group is $66,770 (2013 figures). The United States Bureau of Labor Statistics also states that the salary range for Patent Agents is between $110,000 and $121,800 (2008 figures).

 

 

 

Skills Needed to Become a Regulatory Affairs Specialist

In order to become effective in a career as a regulatory affairs specialist you need to posses a certain set of skills. These skills will help you perform your job duties with competence, and will likely be listed on regulatory affairs specialist job postings.

 

• Able to pay close attention to detail

• Above average reading comprehension skills

• Considerable understanding of both legal and scientific matters

• A thorough understanding of government language and procedures

• Able to grasp new concepts quickly

• Proficient in the use of databases and related software

• Able to assimilate data from a wide range of scientific areas

• Fluency in another language is often considered an asset

 

 

Character Traits of Successful Regulatory Affairs Specialists

In order to enjoy performing the duties of a regulatory affairs specialist and have a long and successful career, you need to have certain personality traits, including:

 

• A strong desire to do work that involves focusing on details

• Enjoy writing and reviewing documents that can be thousands of pages long

• Enjoy collaborating with other professionals

• Able to confidently present reports to management

• Tact, diplomacy and integrity

• An interest in the legislation governing the approval of products

• An interest in working on products that have a mandate to help sick people

 

 

Career Progression for Regulatory Affairs Specialists

With enough experience, regulatory affairs specialists who demonstrate initiative, aptitude and skill can move into senior roles, such as regulatory operations team leader, unit manager or head of regulatory affairs. Due to the necessity of having a broad set of skills and knowledge however, it can take time to progress into these roles.

 

With additional experience in these senior roles, it is possible to move into a position that can influence decisions at the highest level, and senior regulatory affairs specialists and managers often move into executive positions within their organization.

 

Experience regulatory affairs managers are ideal candidates for executive positions, as the broad range of knowledge and skills they have gained in science, business and legal matters give them expertise in critical areas of the operations of their organization.

 

 

Careers Similar to Regulatory Affairs Specialist

Listed below are careers in our database that are similar in nature to Regulatory Affairs Specialist, as they may involve many of the same skills, competencies and responsibilities.

 

Auditor

Compliance Officer

Medical Writer

Patent Agent

Regulatory Affairs Manager

 

 

References

Please use the references below to find more information on the various aspects of a career as a regulatory affairs manager.

 

Covidien website: careers.covidien.com

Prospects website: www.prospects.ac.uk

Sciencemag website: sciencecareeers.sciencemag.org

United States Bureau of Labor Statistics website: www.bls.gov

 

 

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Scholarships for Becoming a Regulatory Affairs Specialist

Scholarships listed for majors that apply to becoming a Regulatory Affairs Specialist can be found on our All Scholarships by Major page.

 

Success Tip: Be sure to apply for any scholarships that you even barely qualify for, as there are millions of dollars of scholarships that go unused every year due to a lack of applicants!

 

 

Becoming a Regulatory Affairs Specialist: Applicable Majors

Studying one of the university majors listed below is an excellent starting point to becoming a regulatory affairs specialist. Click on the links to find out what else you can do with these majors!

 


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