The Associate Director – Regulatory Affairs coordinates inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance. Oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Being an Associate Director – Regulatory Affairs typically reports to top management. Requires a bachelor’s degree in area of specialty. The Associate Director – Regulatory Affairs manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. Extensive knowledge of department processes. Working as an Associate Director – Regulatory Affairs typically requires 5 years experience in the related area as an individual contributor. 1 to 3 years supervisory experience may be required.
Associate Director, Regulatory Affairs Job Description Template
Our company is looking for a Associate Director, Regulatory Affairs to join our team.
Responsibilities:
- Bachelor, Master or PHD in life sciences;
- Submisions of regulatory briefing documents for EMA;
- Experience with dealing with EMA and other regulatory agencies;
- Proven Regulatory Affairs experience in ATMP and GMO;
- Build and maintain relations with EMA, MHRA and other regulatory agencies;
- You will be responsible for compiling and submitting regulatory applications for Pipsm Orphan designations and Maas;
- Willing to travel at 20%
- You have a minimum of 2 years experience in supervising junior regulatory staff;
- Advise and guide affiliates and other internal departments to ensure compliance with UK and European regulations and requirement;
- Speak and write fluent English any other language is preferred;
- In support of clinical trials you will develop and review regulatory submission documents with a specific focus in ATMP and GMO area.
Requirements:
- The regulatory experience must be broad to ensure appropriate leadership and mentoring for regulatory staff;
- Must have Regulatory Affairs experience including developing global prodyct strategies for medicinal products;
- Minimum MSc/ PhD/ PharmD/ M.D. in science or healthcare;
- Line management experience;
- A Degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.