Regulatory Affairs Manager/CMC LZAJP00004740
Vor 2 Tagen
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)
- Participate in process improvement activities/ projects to bring continuous improvement to Regulatory processes e.g. apply Lean methodology
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)
- Strong knowledge of CMC requirements for biologics as well as good procedural knowledge (EU and US; other markets is a plus). In-depth understanding and application of industry standards and global regulations and guidelines
- 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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