REGULATORY AFFAIRS ADVISOR/SENIOR
Our client, a global pharmaceutical company, in order to strengthen its structure, is seeking to recruit a
Regulatory Affairs Advisor/Senior
PURPOSE OF JOB:
The RA Advisor/Senior supports and assists the Regulatory Affairs Manager to manage the activities related to pharma products (medical product, medical device, food supplement, cosmetics and PMC). He/She negotiates with the agencies and national authorities and prepares the whole set of permissions required in pharmaceutical by applying the relevant law/regulations.
The RA Advisor/Senior is responsible for the development of regulatory affairs strategies for submissions and maintenance of Marketing Authorizations/Registrations in EU and extra EU Health Authorities from development to post-market stage.
- Degree in scientific disciplines
- 7 to 10 years of experience in regulatory affairs in the pharmaceutical industry.
- Significant experience with CTD modules and applications (CMC experience is a plus)
- Very detail-oriented, well organized, strong capability to multi-tasks and driven to meet deadlines and program goals. Solid decision-making skills with strategic mindset.
- Ability to work well both independently and in a team environment.
- Excellent communications skills (verbal, written, listening, conveying messages)
- Solid computer skills,
- Fluent English required (oral & written)