A regulatory affairs director works in the private sector, guiding the direction a company takes as it prepares and unveils new products to the market. She oversees compliance and timing as well as defining and paving the ways for government approvals. A regulatory affairs director plays a vital role in interpreting the legal, scientific and marketing plans of drug development companies.
Education
A regulatory affairs director can earn a bachelor's degree in a scientific discipline to begin a career path toward the directorship. A master's degree can set candidates apart from the competition. Appropriate advanced degrees are available that specifically prepare students for jobs in regulatory affairs. Degrees include Master of Science in Regulatory Affairs or a PhD in Regulatory Affairs through an applied science university department.
Entry-level
Many professionals who move into the regulatory side of the industry come to their first position from other jobs in health care, from nursing and engineering to clinical laboratory science and research. Right out of school, regulatory positions available include technical and project coordinator jobs for the first five years or so. Writing and communication skills are vital to succeed in an entry-level regulatory positions as well as a scientific background and a basic knowledge of the legalities involved in the regulatory process.
Experience
On the career path toward a director's position, professionals might spend time in the marketing and sales division of a pharmaceutical company to add to their overall experience. A career path should include some level of management and oversight responsibilities in various divisions of a company. Well-rounded levels of experience for about five years provide important knowledge of the entire cycle of drug approvals.
Considerations
While working, additional professional development courses can help to increase the professional standing of regulatory affairs professionals. Designations such as the Regulatory Affairs Certification (RAC) distinguish those on professional career paths. While not required, certifications provide a measurable validation of the professional's knowledge and commitment to the industry. RAC studies include courses that cover international regulations and procedures for drug development and sales.
Preparation
Prior to seeking a director position in regulatory affairs, a professional should have garnered an average of 10 to 15 years experience in some aspect of the pharmaceutical industry, including prescription drugs and over the counter medications. Candidates for a position will have to show specific examples of participation in successful approval programs as well as demonstrated connections and interactive engagements with governmental regulation officials. Regulatory affairs directors have developed strong leadership skills and the ability to organize teams.
References
Biospace.com: Biotech and Pharmaceutical News & Jobs
Regulatory Affairs Professionals Society
Chemical and Engineering News
