Deputy CPO, Regulatory & Quality Lead (France)

Alnylam Pharmaceuticals; Paris; Hybrid; EUR 120,000 - 160,000; Full time

Job summary

Alnylam Pharmaceuticals in Paris seeks a senior regulatory and quality leader to act as the Deputy Chief Pharmaceutical Officer, providing strategic and operational oversight of French and European regulatory affairs, pharmacovigilance, and promotional compliance.

The role collaborates across Regulatory, Medical Affairs, PV, QA, and Commercial functions, ensuring alignment with French Public Health Code provisions and global strategies for centralized procedures and development activities.

Qualifications

• PharmD with relevant experience registered with Ordre des Pharmaciens (section B).
• Extensive knowledge of French/European Regulatory requirements for innovative products in late-stage development and post-approval.
• Experience with Centralized procedure and promotional activities in France.
• Experience liaising with ANSM and regulatory authorities.

Responsibilities

• Serve as the Deputy Chief Pharmaceutical Officer when deputising for RP/CPO.
• Lead regulatory guidance on product information, promotional materials, and medical communications in France.
• Act as local French regulatory lead for assigned products, aligning local execution to global strategy.
• Oversee pharmacovigilance activities, educational materials approval, and LSO duties.
• Ensure compliance with quality defects handling and batch recalls as needed.
• Supervise distribution and monitoring of supplies to ensure continuous availability.
• Contribute to product quality reviews and QMS implementation to respond to regulatory changes.
• Support audits, promotions chart, and interactions with Healthcare Professionals and anti-gift laws.
• Foster partnerships with external consultants, CROs, and regulatory bodies to advance objectives.

Skills

Regulatory affairs

Pharmaceutical quality

Pharmacovigilance

Promotional compliance

Cross-functional collaboration

Product supply oversight

Healthcare compliance

Education

PharmD (Ordre des Pharmaciens)

Job description

Alnylam Pharmaceuticals in Paris seeks a senior regulatory and quality leader to act as the Deputy Chief Pharmaceutical Officer, providing strategic and operational oversight of French and European regulatory affairs, pharmacovigilance, and promotional compliance.

The role collaborates across Regulatory, Medical Affairs, PV, QA, and Commercial functions, ensuring alignment with French Public Health Code provisions and global strategies for centralized procedures and development activities.