Regulatory affairs specialist Jobs in Basel
Zuletzt aktualisiert: vor 5 Tagen
Regulatory Affairs Manager
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ExponentBasel, CH Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Executive Director, Public Affairs Strategy
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nemensisSwitzerland, Basel-Landschaft, Basel-Land Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Affairs Manager (m / w / d)
HaysBasel Stadt Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Associate Medical Affairs / Medical Information (m / w / d) 50-70%
Teva PharmaceuticalsBasel, Switzerland Mehr anzeigenZuletzt aktualisiert: vor 23 Tagen
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Regulatory Affairs Manager
CTCBasel and NW Switzerland, CHVor 18 Tagen
StellenbeschreibungRelevant 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); Good CMC writing skills; Previous experience in contractor environment e.g. CMO / CDMO, CRO, Consultancy is an advantage.
Main Responsibilities :
- Author and review CTD module 3.2 sections (drug substance / drug product) for biologicals 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.
Qualifications and Experience :