Regulatory Affairs Specialist
hace 8 horas
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Galderma. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products.
Key Responsibilities:
- Contribute to global regulatory CMC strategies
- Assess regulatory impact of proposed CMC changes and contribute to CMC regulatory strategies
- Review data provided to support dossier preparation and identify gaps and risks
- Write and assemble CMC sections of regulatory submissions
- Develop and maintain project plans and schedules for CMC submissions
- Ensure all CMC dossiers are stored in the company database
- Provide guidance on ICH, FDA, and EU CMC guidelines
- Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations, and other relevant partners
- Share knowledge and experience with other team members
Requirements:
- Effective experience in CMC Regulatory Affairs
- Background in pharmaceutical industry
- Experience with topical and/or systemic drugs (Biologics and/or Small Molecules)
What We Offer:
- A competitive compensation package with bonus structure and extended benefit package
- A hybrid work culture
- Feedback loops and personalized career path
- Ownership and accountability from day one
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