Manager Regulatory Affair at Capgemini Engineering coordinating activities for the US market. Preparing submissions to the FDA and collaborating with internal teams for regulatory compliance.
About the role
- Regulatory-CMC Development Expert supporting strategic projects at Pierre Fabre, a top dermo-cosmetics laboratory. Focus on CMC regulatory strategy from trials to marketing applications.
Responsibilities
- Develop, in collaboration with the CMC team, the CMC development plan up to the Marketing Authorization Application (MAA).
- Propose innovative CMC regulatory strategies.
- Ensure integration of regional regulatory specificities into global CMC plans.
- Identify and assess CMC regulatory risks.
- Participate in CMC project teams, global project teams and regulatory project teams.
- Prepare briefing documents related to regulatory positioning.
- Assess the regulatory impact of proposed changes to assigned products.
Requirements
- Master's degree or equivalent scientific qualification
- Minimum of 8 years' relevant experience, preferably in CMC regulatory development or CMC R&D
- Knowledge of small molecules and biological products is a plus
- Ability to work independently and as part of a team
- Strong stakeholder engagement skills (internal and external)
- Excellent written, verbal and interpersonal communication skills
- Highly organized
- Familiarity with Veeva Vault RIM or similar regulatory tools preferred
- Fluency in English required
- Ability to work in an international environment
Benefits
- Incentives
- Profit-sharing
- Employee share ownership plan in Pierre Fabre with employer contribution
- Health insurance and welfare coverage
- 16 RTT days in addition to 25 days of annual leave
- Commuter/transport allowance
- Attractive Works Council (employee benefits) offerings
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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