Regulatory Affairs Specialist
hace 4 semanas
We are seeking an experienced Regulatory Affairs CMC 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 and assess the impact of proposed CMC changes.
- Review data provided to support dossier preparation, identify gaps and risks, and work with stakeholders to resolve them.
- 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 and 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 to ensure alignment of regulatory CMC strategies.
- Effective experience in CMC Regulatory Affairs, background in the pharmaceutical industry, and experience with topical and/or systemic drugs.
- A competitive compensation package with bonus structure and extended benefit package.
- A hybrid work culture that allows for flexibility and work-life balance.
- Opportunities for professional growth and development, including feedback loops and personalized career paths.
- Send your CV in English.
- If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.
- The next step is a virtual conversation with the hiring manager.
- The final step is a panel conversation with the extended team.
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