Chef de projet Affaires Réglementaires (H/F)

Biogaran is a French drug manufacturer focused on meeting the needs of patients and healthcare professionals, aiming to ensure the proper use of medications. The Regulatory Affairs Project Manager will be responsible for the management of regulatory aspects, including AMM submissions, product lifecycle management, and pharmacovigilance activities. The role involves contributing to the company's mission of improving health through innovative and ethical solutions.

Requirements

• Pharmacist or higher scientific education or holding a MASTER’S degree.
• 4 to 5 years of experience in Regulatory Affairs (pharmaceuticals).
• Mastery of relevant regulations (European and French).
• Knowledge of e-CTD format and CMC issues.
• Strong track record in regulatory strategy.
• Fluency in English.
• Flexibility and prioritization skills.
• Strong communication skills.
• Ability to prioritize projects.