Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm Research & Manufacturing is a pharmaceutical research, development and production company with GMP facilities certified by the major regulatory authorities. It is the center of expertize for medicinal chemistry for the Group. The company is a world leader in polylactic-co-glycolic acid (PLGA)-based injectables.
For his Technical Operations Department, Debiopharm Research & Manufacturing in Martigny is looking for a
Regulatory Affairs Manager, 100%
Manage post marketing regulatory activities of drug products including extension of indications in Switzerland, USA and Canada.
- Maintenance of Swiss registration files,
- Maintenance of DMF drug products in USA and Canada,
- Coordinate with partners' regional regulatory teams for global strategy,
- Act as liaison with Swissmedic,
- Define, develop and lead regulatory strategies for assigned territories,
- Prepare and review regulatory submissions,
- Internal Regulatory contact for Pharmacovigilance and Marketing for Switzerland,
- Maintain policy & regulatory intelligence,
- Provide regulatory strategies for projects as RA representative in cross-functional teams.
Education and Experience
- Degree in Science (e.g. Chemistry, Pharmacy) or equivalent,
- 10 years' experience in Pharmaceutical regulatory affairs in Switzerland, USA and Canada for sterile parenteral drugs,
- Maintenance, Renewal, Extension of indications,
- Previous experience in meeting with Health agencies,
- US and Canada Regulations for DMF,
- Fluent in French, English and German,
- Strong attention to details and organizational skills required,
- Good written and oral communication, technical writing and editing skills.
If you fit this profile please send your application using this form.