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
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