Regulatory Affairs Manager/cmc

vor 3 Wochen


Basel, Schweiz Coopers Group AG Vollzeit

Regulatory Affairs Manager/CMC

Duration: 30/10/2025, possible extension

**Key Responsibilities**:

- Manage timely responses to Health Authority (HA) questions (author/ review)
- Draft/ review briefing documents to support e.g. scientific advice procedures/ meetings with HA
- Lead/ coordinate/ communicate/ track/ activities to ensure submission deadlines are met in accordance with procedures: e.g. planning, liaising with Subject Matter Experts (SME) and Projects Managers (PM), collaborate internally/externally on Clients projects
- Communicate and escalate risks and issues to management and project teams, as applicable;
- Act as RA Point of Contact or RA team member for assigned projects e.g. attend meetings with clients, provide regulatory advice
- Change Controls and Deviations
- Perform Regulatory assessments for change controls and deviations to ensure compliance with internal procedures and regulations
- Support site-specific regulatory documentation and activities: maintenance of sites facility registrations filings with regulatory agencies and plant-level documentation (e.g. Site Master File and Japan FMA)

**Requirements**:

- Advanced knowledge in Life Sciences (e.g. Molecular and Cell Biology, Biochemistry, Microbiology) and Pharmaceutical Sciences (e.g. injectables): good understanding of manufacturing processes and quality control for biological medicinal products (e.g. Mammalian, Microbial, Conjugates, Vaccines, Sterile products)
- Experience (at least 5 years) in authoring high-quality CMC CTD sections (content and format) for drug substance, drug product, and appendices from first-in-human to post-approval for biological medicinal products
- Good CMC writing skills

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