Regulatory Affairs Specialist
hace 4 semanas
We are seeking an expert in Regulatory Affairs to join our team at Galderma. This role will focus on preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products.
The ideal candidate will have experience in CMC Regulatory Affairs and a background in the pharmaceutical industry. They will be responsible for developing and maintaining project plans and schedules for CMC submissions, ensuring all CMC dossiers are stored in the company database, and providing guidance on ICH, FDA, and EU CMC guidelines.
The successful candidate will also be responsible for developing and maintaining excellent relationships with internal functional groups, contract manufacturing organizations, and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory goals.
Key responsibilities include contributing to global regulatory CMC strategies, assessing regulatory impact of proposed CMC changes, and reviewing data provided to support dossier preparation.
As a member of our team, you will have the opportunity to work with a diverse group of professionals who are passionate about delivering high-quality results. You will also have access to a competitive compensation package, bonus structure, and extended benefit package.
We value professionalism, collaboration, and a friendly, supportive ethos, and we believe that our team members are empowered to grow and take on accountability from day one.
Our hiring process includes a virtual conversation with Talent Acquisition, a virtual conversation with the hiring manager, and a panel conversation with the extended team.
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Regulatory Affairs Specialist
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