Project Regulatory Engineer at SBM Offshore ensuring adherence to global regulatory requirements. Collaborating with cross - functional teams for seamless integration of regulatory standards throughout project lifecycle.
About the role
- Regulatory-CMC Development Expert supporting strategic projects at Pierre Fabre, a leader in dermo-cosmetics and pharmaceuticals. Responsible for CMC regulatory strategy from early clinical trials to marketing applications.
Responsibilities
- Responsable for the CMC regulatory strategy for assigned projects
- Provide CMC regulatory expertise to the pharmaceutical development team
- Develop the CMC development plan in collaboration with the pharmaceutical CMC team
- Propose innovative CMC regulatory pathways
- Ensure that regional regulatory requirements are integrated into global CMC plans
- Identify and communicate CMC regulatory risks
- Manage preparation of briefing documents for regulatory positioning
- Assess the CMC regulatory impact of all proposed changes for the assigned product
Requirements
- Master's degree or equivalent scientific qualification
- Minimum of 8 years of relevant professional experience, preferably in CMC regulatory development or CMC R&D
- Knowledge of small molecules and biologics is a plus
- Ability to work independently and as part of a team
- Strong stakeholder engagement skills with internal and external partners
- Good written, verbal, and interpersonal communication skills
- Highly organized
- Familiarity with Veeva Vault RIM or similar regulatory tools is a plus
- Proficiency in English is required
- Ability to work in an international environment
Benefits
- Incentive schemes
- Profit-sharing
- Pierre Fabre employee share ownership plan with employer contribution
- Health insurance and welfare benefits
- 16 additional RTT days plus 25 paid leave days
- Public transportation subsidy
- Very attractive employee benefits committee (CE)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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