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Regulatory Affairs Manager

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%

 

Mission
Manage post marketing regulatory activities of drug products including extension of indications in Switzerland, USA and Canada.

 

Key Responsibilities

  • 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.