Regulatory Affairs Specialist
il y a 2 semaines
Debiopharm, a pharmaceutical research, development, and production facility based in Martigny, Switzerland, is dedicated to improving patient quality of life. The company specializes in oncology and bacterial infections, focusing on innovative therapies for high unmet medical needs.
Role OverviewWe are seeking an experienced Regulatory Affairs Specialist to join our team. This role will be responsible for ensuring compliance with regulatory requirements, maintaining up-to-date product information, and managing the company's Regulatory Information Management System.
Key Responsibilities- Maintain and update Product Information, ensuring accuracy and compliance with regulatory standards.
- Manage the Regulatory Information Management System, staying up-to-date with the latest regulatory developments.
- Collaborate with cross-functional teams to ensure effective interactions and communication.
To succeed in this role, you will need:
- Good knowledge of ICH Quality standards, European and US pharmacopoeias, and International CMC Guidances, including ASEAN.
- Fluent language skills in French and English.
The estimated salary range for this position is CHF 90,000 - CHF 120,000 per year, depending on experience and qualifications.
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Regulatory Affairs Professional
il y a 2 semaines
Avranches, Normandie, France Debiopharm Temps pleinJob Title: Regulatory Affairs ManagerAbout UsDebiopharm, a Swiss-based biopharmaceutical company, specializes in developing innovative therapies for oncology and bacterial infections. Our mission is to improve patient quality of life by addressing high unmet medical needs.About the JobWe are seeking an experienced Regulatory Affairs Manager to join our team...