Associate Director, Regulatory & Pharmaceutical Affairs

About the role

This senior role acts as the deputy to the Responsible Pharmacist and Chief Pharmaceutical Officer, supporting the oversight and execution of pharmaceutical responsibilities in France. The position combines regulatory affairs, quality, pharmacovigilance, and compliance to ensure activities align with French and European requirements. The incumbent provides strategic guidance and operational leadership, acting as a key partner to the CPO in managing regulatory risks and pharmaceutical operations.

Responsibilities

• Participate in cross-functional regulatory initiatives integrating perspectives from Commercial, Medical Affairs, and Quality.
• Provide regulatory guidance on promotional and non-promotional materials to ensure alignment with legal requirements.
• Act as the local French regulatory lead for assigned products and support clinical study development activities.
• Manage pharmacovigilance activities, including reconciliation and approval of educational materials.
• Collaborate with the Responsible Pharmacist on quality defects, batch recalls, and supply monitoring.
• Implement process reviews and maintain the pharmaceutical quality management system.
• Ensure compliance with the French Public Health Code when deputising for the Chief Pharmaceutical Officer.

Required skills

• Regulatory Sciences
• Pharmacovigilance
• Quality Assurance
• French Public Health Code
• Regulatory Affairs
• ANSM interaction

Nice to have

• Compassionate use programs
• Contract management
• Audit management

Qualifications

• PharmD registered with Ordre des Pharmaciens (section B)
• Experience with French/European regulatory requirements for innovative products
• Experience in promotional activities and interaction with medical/commercial teams

About the Company

Alnylam Pharmaceuticals has led the translation of RNA interference into a new class of innovative medicines to treat diseases at their genetic source. Founded in 2002, the company is recognized as a top biopharma employer with a people-first culture focused on innovation and excellence.