Scientific affairs manager Jobs in Basel
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Regulatory Affairs Manager
CTCBasel and NW Switzerland, CH Mehr anzeigenZuletzt aktualisiert: vor 6 Stunden
- Gesponsert
Senior Manager, Public Affairs Governance
myGworkBasel (City), Switzerland Mehr anzeigenZuletzt aktualisiert: vor 2 Tagen
Scientific Business Analyst (f / m / d)
ITech Consult AGBaselENRICHMENT - Guest Lecturer - World Affairs
VikingBasel, Switzerland Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Principal - Real-World Evidence Consulting - Switzerland
IQVIABasel, Switzerland- Gesponsert
Medical scientific affairs manager (w / m / d)
Gi Group SABasel Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Affairs Manager (m / w / d)
bruederlinpartnerBasel, BS, CHAssociate Medical Director Clinical Science
SobiBasel, Basel-Stadt, SwitzerlandManager, Regulatory Affairs
LonzaBasel, Switzerland Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Head of International Regulatory Affairs - Apraglutide
Ironwood PharmaceuticalsBasel, Switzerland Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
REACH Regulatory Project Manager
ExponentBasel, CHSenior Manager – CMC Dossier Manager (M / F)
Aixial GroupBasel Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Senior Manager Public Affairs - Established Pharmaceuticals Division
AbbottBasel, Basel-City, Switzerland Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Scientific Business Analyst (m / f / d)
Coopers Group AGBasel-Stadt, SwitzerlandRegulatory Affairs Consultant Schweiz
gloor&lang AGBasel, Basel City, SwitzerlandDigital Biomarker Scientific Solutions Manager
RocheCity, SwitzerlandScientific Associate Bioinformatics
Real StaffingBasel-City, SwitzerlandRegulatory Affairs Manager (m / w / d)
HaysBasel StadtAssociate Medical Affairs / Medical Information (m / w / d) 50-70%
Teva PharmaceuticalsBasel, Switzerland Mehr anzeigenZuletzt aktualisiert: vor 5 Tagen
Senior Scientific Assistant
The Biozentrum, University of BaselBasel, CH Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Regulatory Affairs Manager
CTCBasel and NW Switzerland, CHVor 6 Stunden
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 :