For his Technical Operations Department, Debiopharm Research & Manufacturing in Martigny is looking for a Regulatory Affairs Manager, 100%

22.02. | Employé | 100%

Debiopharm is a private, Swiss-based biopharmaceutical company. Mainly focused in oncology and bacterial infections, the company develops innovative therapies that target high unmet medical needs with an ambition to improve patient quality of life. Debiopharm Research & Manufacturing S.A., based in Martigny, is a pharmaceutical research, development and production facility, inspected and registered with the main regulatory authorities. The Company is a world leader in polylactic-co-glycolic acid (PLGA)-based injectable, sustained-release technology.

 

Regulatory Affairs Manager

Mission :

Manage post marketing regulatory activities of drug products including extension of indications.

 

Key Responsibilities :

  • Maintenance of registration files Asean and Middle East countries
  • Maintenance of API DMF
  • Prepare registration files for new territories in Middle East and Asean countries
  • Coordinate with partners’ regional regulatory teams for global strategy
  • Define, develop and lead regulatory strategies for assigned territories
  • Maintenance and update of the Product Information
  • Prepare and review regulatory submissions
  • Internal Regulatory contact for Pharmacovigilance and Marketing and Business
  • 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
  • 5 years’ experience in Pharmaceutical regulatory affairs for sterile parenteral chemical drugs, ideally prolonged-release formulation
  • Experience in preparation and maintenance for DMF for chemical API
  • Experience with Chinese Authorities
  • Maintenance, Renewal, Extension of indications
  • Previous experience in meeting with Health agencies
  • Fluent in French and English
  • Strong attention to details and organizational skills required
  • Good written and oral communication, technical writing and editing skills