The development of a pharmaceutical or biotechnological company requires the appropriate registering of its products and the periodic renewal of market authorizations. Obtaining approvals from regulatory agencies (Canadian, American, European) and Health Canada’s Therapeutic Products Directorate (TPD) is crucial. Departments mainly concerned with these regulations are research, development and production.
Regulatory affairs specialist job description
The mission of the Regulatory Affairs Specialist (RAS) is to prepare and file demands for regulatory approval of the products of one’s company. Biotechnology companies, which have lesser means than large pharmaceutical companies, prioritize experienced candidates or else turn to consultants. The Regulatory Affairs Specialist in biotechnology thus plays a very strategic role and is involved in all stages of the process, whereas its counterpart in the pharmaceutical industry has more delineated responsibilities, involving more administrative tasks.
The Regulatory Affairs Specialist stays with the same company for an average of 10 to 15 years; the rate of turnaround is therefore low. Networking is very much encouraged, through joining various associations to participate in conferences and exhibitions, and also to access current literature. Presently, there is a strong demand for Regulatory Affairs Specialists in medical device companies.
Main duties of the regulatory affairs specialist
- Prepare, coordinate and supervise regulatory submissions
- Review product conformance and assure compliance
- Implement different strategies in order to meet evolving regulatory initiatives
- Register products according to provincial guidelines and regulations of third party suppliers
- Keep current with regulations
- Participate in conferences and interdepartmental meetings
Education to become a regulatory affairs specialist
It is recommended to have a university degree in the sciences (Bachelor’s, Master’s, PhD), whether it be in biology, chemistry, toxicology, pharmacology, etc.
Skills
- Expertise in laboratory analysis, manufacturing procedures and clinical testing
- At minimum, thorough understanding of Canadian regulations (familiarity with American and European regulations an asset)
- Broad knowledge of mathematics, physics, chemistry and biology
- Strong computer skills
- Must be bilingual
Personal characteristics
- Strategic and innovative spirit
- Attention to detail
- Maturity, autonomy and sound judgment
- Organizational skills
- Interpersonal skills
- Writing skills
Advancement
The Regulatory Affairs Specialist will advance in stages. By the end of the first year, he/she will begin to have a command of the subject. After three years of professional experience, he/she will be able to work independently and prepare regulatory submissions. After 10 to 15 years, he/she will be considered a senior specialist.
If the Regulatory Affairs Specialist excels in obtaining approvals and develops skills in communication, marketing and management, there are numerous other opportunities: in development (project manager, developmental coordinator), outside relations with regulatory agencies…