How to Become a Regulatory Affairs Manager: Career Path Guide
If you want to become a regulatory affairs manager, 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 manager:
• You enjoy managing people
• You have an interest in working on products that have a mandate to help sick people
• 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
• You are willing to be take responsibility for the failure or success of products that can be worth hundreds of millions
Below we've outlined what you'll need to begin a career as a regulatory affairs manager. 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!
Education Needed to Become a Regulatory Affairs Manager
The educational requirements for becoming a regulatory affairs manager vary by employer, although you typically need a master’s degree in science (M.Sc.), a medical degree (M.D.) or Doctorate (Ph.D.) to work in this profession.
There is a great deal of responsibility associated with a career as a regulatory affairs manager, and employers prefer to hire candidates with advanced levels of education and industry experience.
Regulatory Affairs Manager Job Description
The regulatory affairs manager within an organization works at the interface between business and government regulations, overseeing the development of medical and healthcare products from inception to market. Their ultimate goal is to ensure that new products meet certain requirements as set by government legislation or other regulatory boards.
The main responsibility of a regulatory affairs manager is to lead and support the regulatory affairs personnel. In addition to overseeing staff, the regulatory affairs manager typically participates in all activities relating to registration and regulation compliance.
Regulatory affairs managers typically work for companies that produce and market healthcare products, such as biotech and pharmaceutical products, medical devices and diagnostic equipment, cosmetics, and nutritional products.
Regulatory Affairs Manager Job Duties
• Update all licensing and collect information on registration instructions and regulations
• Implement Quality Assurance systems
• Manage the final submission for product approval
• Provide project team with regulatory input in order to obtain timely regulatory approvals
• Defend company business interest in international standardization groups
• Manage a team of several regulatory affairs officers
• Maintain current knowledge of regulatory standards within jurisdictions of business activity
• Develop partnerships with other internal departments and establish key relationships with external agencies
• Stay abreast with world’s ever-changing regulatory requirements
Experience Needed to Become a Regulatory Affairs Manager
Those who become regulatory affairs managers often have experience as regulatory affairs specialists, as well as experience in other relevant areas (such as research or quality assurance) within the healthcare, pharmaceutical and medicinal product industry.
Those who become regulatory affairs managers may also make the transition into the career field from the other side of the regulatory fence; they may have gained experience with agencies that regulate healthcare, pharmaceutical and medicinal products.
Although relevant experience is often required if you want to become a regulatory affairs manager, some companies, such as contract research organizations and consultancies, may be willing to employ individuals with exceptional skills and invest in their career training.
Success Tip: Industry knowledge is key to becoming a regulatory affairs manager. Having experience and knowledge of research, clinical work, toxicology, pharmaceuticals, manufacturing techniques and relevant aspects of the law are of paramount importance if you want to work in regulatory affairs management.
Who Creates Jobs for Regulatory Affairs Managers?
Regulatory affairs managers are typically hired 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
• Consultancies
• Healthcare and medicinal product regulatory agencies
Regulatory Affairs Manager Salary
The salary level of regulatory affairs managers can vary based on their level of education, their level of experience, the size and type of their employer, the region in which they work, and many other factors.
There is no salary information available from reliable sources specifically for the career Regulatory Affairs Manager. We can however get a good idea of what workers in this occupation earn by looking at the salary levels of workers in closely related fields.
Regulatory Affairs Manager United States: According to the United States Bureau of Labor Statistics, the salary range for Patent Agents is between $110,000 and $121,800 (2008 figures).
Skills Needed to Become a Regulatory Affairs Manager
In order to become effective in a career as a regulatory affairs manager, and perform your job duties with competence, you need to posses a certain set of skills, including:
• Excellent attention to detail
• Excellent reading comprehension skills
• Considerable understanding of both legal and scientific matters
• An understanding of government language and procedures
• Able to grasp new concepts quickly
• Proficient in the use of databases
• Able to manage tiny nuances of data in a multi-gigabyte document
• Able to assimilate data from a wide range of scientific areas
• Fluency in another language is often considered an asset
Personality Traits Needed to Become a Regulatory Affairs Manager
In order to enjoy performing the duties of a regulatory affairs manager, you need to have certain personality traits. Taking enjoyment from your duties as a regulatory affairs manager is important, as it helps you maintain a positive attitude towards your work, which usually leads to having a long and successful career.
• A strong desire to do detail work; a pronounced love of detail
• Willing to write and review documents that can be thousands of pages long
• Enjoy collaborating with experts in field of expertise
• Able to confidently present reports to executive management
• Tact, diplomacy and integrity
• A keen interest in the legislation governing the approval of products
• A keen interest in working on products that have a mandate to help sick people
• You are willing to be take responsibility for the failure or success of products that can be worth hundreds of millions
Careers Similar to Regulatory Affairs Manager
Listed below are careers in our database that are similar in nature to Regulatory Affairs Manager, as they may involve many of the same skills, competencies and responsibilities.
• Auditor
References: Regulatory Affairs Manager Career Information
Please use the references below to find more information on the various aspects of a career as a regulatory affairs manager.
Occupational Employment and Wages: “Compliance Officers.” (December 4, 2019). Bureau of Labor Statistics - United States Government website. Retrieved January 12, 2020.
Careers: “Tooling Up: The Regulatory Affairs Career Track.” David G. Jensen (September 18, 2009). American Association for the Advancement of Science website. Retrieved January 12, 2020.
Job Profile: “Regulatory Affairs Manager.” AGCAS editors (November, 2019) Prospects website. Retrieved January 12, 2020.
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Scholarships for Becoming a Regulatory Affairs Manager
Scholarships listed for majors that apply to becoming a Regulatory Affairs Manager 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 Manager: Applicable Majors
Studying one of the university majors listed below is an excellent starting point to becoming a regulatory affairs manager. Click on the links to find out what else you can do with these majors!
