(Senior) Associate Regulatory Affairs

Description de poste

We are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join our pharmaceutical company. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally (internationally).

Group 10 Responsibilities :

• Prepare and submit regulatory documents (INDs, NDAs, BLAs, MAAs, etc.)
• Ensure compliance with laws, regulations, and guidelines established by regulatory agencies and national regulatory authorities
• Collaborate with cross-functional teams during product development to ensure regulatory compliance from the early stages of research and development through to commercialization
• Oversee the development of product labeling and packaging materials to ensure compliance with regulatory requirements
• Manage regulatory aspects of clinical trials, including obtaining regulatory approvals, ensuring compliance with Good Clinical Practice (GCP) guidelines
• Monitor and report adverse events and other safety issues associated with pharmaceutical products to regulatory authorities as required by pharmacovigilance regulations
• Work closely with quality assurance and quality control teams to ensure that pharmaceutical products are manufactured, tested, and distributed in compliance with current Good Manufacturing Practice (cGMP) regulations
• Prepare for and participate in regulatory inspections and audits conducted by health authorities

Group 12 Experience :

• Bachelor’s degree in pharmacy, life sciences, or a related field
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry
• Strong knowledge of regulatory requirements for drug development, approval, and marketing in the EU, and other major markets
• Excellent written and verbal communication skills in French and English, with the ability to effectively communicate complex regulatory requirements to cross-functional teams
• Proven ability to work independently and collaboratively in a fast-paced environment, with a strong attention to detail and accuracy
• Experience with regulatory submissions and interactions with health authorities is preferred
• Familiarity with pharmacovigilance regulations and adverse event reporting is a plus