Regulatory Affairs Manager
Vor 3 Tagen
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Responsibilities:- Author and review CTD module 3.2 sections (drug substance/ drug product) for biological medicinal products;
- Prepare high-quality clinical trials applications, BLA/ MAA, and post-approval submissions;
- Manage timely responses to Health Authority (HA) questions;
- Lead and coordinate activities to ensure submission deadlines are met;
- 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;
- Manage change Controls and Deviations;
- Support site-specific regulatory documentation and activities.
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- A Bachelor’s or Master’s degree in Biology, Chemistry, Biochemistry, Pharmacy or equivalent;
- 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 understanding of manufacturing processes and quality control for biological medicinal products;
- Strong knowledge of CMC requirements for biologics as well as good procedural knowledge (EU and US; other markets is a plus);
- Previous experience in contractor environment e.g. CMO/CDMO, CRO, Consultancy is an advantage.
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Regulatory Affairs Manager
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