Senior Regulatory Affairs Specialist
On-siteParis, Île-de-France, France
Job Summary
Lead country-level regulatory activities for medicinal products, ensuring compliance with local requirements and managing the full product lifecycle. Prepare, coordinate, and submit regulatory documentation for variations, renewals, notifications, line extensions, and new marketing authorization applications. Act as the key regulatory contact for clients and Health Authorities, driving submissions through successful approval. Review and approve promotional and non-promotional materials, artwork, and labelling updates in France to ensure adherence to local laws and industry codes. Monitor legislative changes and assess business impact while collaborating with cross-functional teams to support business objectives. This fixed-term 12-month contract requires fluency in French and English.
Required Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, or a related scientific discipline
- Significant experience in Regulatory Affairs within the pharmaceutical industry
- Experience in management of post-approval regulatory activities
- Experience in product lifecycle maintenance
- Strong knowledge of local pharmaceutical legislation
- Strong knowledge of regulatory requirements
- Strong knowledge of submission procedures
- Experience in Lifecycle Management activities
- Experience with variations
- Experience with renewals
- Experience with labelling updates
- Experience with maintenance of marketing authorizations
- Proven ability to manage multiple projects simultaneously
- High level of accuracy
- Attention to detail
- Strong stakeholder management skills
- Strong communication skills
- Strong problem-solving skills
- Ability to work independently
- Ability to collaborate effectively within global and local teams
- Fluent written communication skills in French
- Fluent verbal communication skills in English
Desired Qualifications
- Advanced computer skills, including MS Office
- Experience with regulatory information management systems
- Experience with artwork review tools
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