Regulatory Affairs Manager (f/m) (office or home based - France)
support from a specialized team dedicated to meeting or exceeding our clients expectations.
dynamic work environment as well as career development opportunities.
- Preparation and coordination of Clinical Trial Applications, including local submission procedures and local regulatory requirements
- Compilation and review of all documents required for the submission to the Competent Authority, Ethics Committee and Institutional Review Boards
- Submission of all relevant study documents to EC/IRB, CA, local authorities and institutions.
- Preparation of core dossiers for other affiliates or subcontractors for submissions in other countries
- Ensuring that clinical trials applications are conducted according to local and international requirements/procedures (ICH-GCP, applicable local law and guidelines, applicable SOPs)
- Assistance with regulatory intelligence by monitoring the global regulatory environment and providing regulatory summaries
- Collaboration with Clinical Operations and other internal departments if needed
- Representing Regulatory Affairs in project teams and towards customers
- Bachelor's degree in business, life sciences or a related field of study
- 5+ years Regulatory Affairs experience in a CRO or the pharmaceutical industry
- Strong understanding and knowledge of local requirements of Ethics Committees and Competent Authorities submission procedures according to international and national laws and guidelines
- Experience in Marketing Authorization Applications, regulatory life-cycle management and Medical Device experience would be an asset
- Proficiency in MS Office and regulatory databases
- Effective verbal and writing skills (English)