How to become a Regulatory Affairs Specialist
Regulatory Affairs Specialist (SAR)
The development of a company in the pharmaceutical or biotechnology requires the proper registration of its products and the periodic renewal of licenses. Obtaining approvals from regulatory agencies (Canadian, American, European) with the Therapeutic Products Directorate of Health Canada (TPD) is crucial. The main departments involved in this approval are research, development and production.
Regulatory Affairs Specialist Description
The mission of the Regulatory Affairs Specialist (SAR) is to prepare and submit applications for registration for the products of the company that employs him. Biotechnology companies, which have fewer resources than substantial pharmaceutical companies, prefer experienced candidates or the use of consultants. SAR plays a real strategic role, and is involved in all stages of the process, unlike its counterpart in a large group that has a position more segmented with more administrative tasks.
The SAR is averaged from 10 to 15 years in the same company; the turnover rate is low. It is recommended to encourage networking by joining various associations to participate in seminars and trade shows, and also for access to recent publications. There is currently a high demand for SAR for medical device companies.
- Prepare, coordinate and monitor applications for registration
- Review compliance labels and communication equipment
- Develop strategies to ensure compliance with regulatory guidelines
- Take the steps to register the products to provincial formularies and payers
- Make regulatory monitoring
- Participate in interdepartmental meetings and conferences and symposia
It is recommended to have a university degree in science (bachelors, masters, doctoral) whether in biology, chemistry, toxicology, pharmacology and others.
Regulatory Affairs Specialist Skills
- Have a good expertise in laboratory analysis, manufacturing processes and in clinical trials
- Know at least the Canadian regulations (regulations about American or European is an asset)
- Have good knowledge in mathematics, physics, chemistry and biology
- The master computer
- Be bilingual
- Strategic thinking and innovative approach
- Attention to detail
- Maturity, autonomy and decision
- Organization
- Relational qualities
- Easy to write
The salary of a young specialist in regulatory affairs is in the range of 50 to $ 70 000. Average earnings, regardless of the number of years of professional experience, is about $ 90 000.
Regulatory Affairs Specialist Professional development
The Regulatory Affairs Specialist will progress in stages. At the end of the first year, it will begin to master the subject. After three years of professional experience, the SAR will be autonomous and may submit only one bid. Between ten and fifteen years of practice in this position, it will be considered senior.
If the specialist regulatory affairs have excelled in obtaining approvals and has been able to develop communication skills, marketing and management, so many opportunities offered to them: development (Project Manager, Development Planning) external relations of the certification bodies, technological ...
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