Regulatory Affairs Manager

☞ Debiopharm

Vue: 148

Jour de mise à jour: 25-03-2024

Localisation: Martigny Valais VS

Catégorie: Juridique / Contrats

Industrie: Pharmaceutical Manufacturing

Niveau: Associate

Type d’emploi: Full-time

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le contenu du travail

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.



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 chemical pharmaceutical drug products including extension of indications.

Manage regulatory activities of chemical pharmaceutical drug products under development.

Key Responsibilities :

  • Maintenance of registration files
  • Coordinate with partners’ regional regulatory teams for global strategy
  • Define, develop and lead regulatory strategies for post-marketing and clinical development activities
  • Maintenance and update of the Product Information
  • Prepare and review regulatory submissions
  • Manage CMC activities for products under development
  • 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

Requirements:

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 regulatory activities for Chemical Pharmaceutical Drug Products under development (phase 1 to phase 3)
  • 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
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Date limite: 09-05-2024

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