Senior Manager, Regulatory Affairs, Advertising and Promotion

About the role

The Senior Manager, Regulatory Affairs, Advertising and Promotion will lead the day‑to‑day regulatory review of advertising, promotional and educational materials for Servier’s US products. Reporting to the Director of US Regulatory Affairs and Quality Management, the role partners with Marketing, Medical Affairs and Legal to ensure compliant, scientifically sound messaging.

Key responsibilities

• Lead regulatory review and approval of advertising, promotional, and disease‑state materials for assigned US products.
• Ensure all promotional initiatives comply with FDA regulations and OPDP guidance.
• Serve as the regulatory representative on the Promotional Review Committee and Medical Scientific Review Committee.
• Oversee preparation and timely submission of FDA Form 2253 for US promotional materials.
• Provide strategic guidance on conference exhibits, speaker programs, and digital communication strategies.
• Monitor FDA enforcement actions and conduct impact analyses for internal stakeholders.
• Develop and implement SOPs for the promotional review process and maintain regulatory documentation for audit readiness.

Required profile

• Bachelor’s degree in a scientific or healthcare field.
• 5+ years of regulatory affairs experience in advertising and promotion within biotech/pharma, preferably oncology or rare disease.
• Strong knowledge of FDA regulations and OPDP guidance.
• Experience managing product launches and cross‑functional collaborations.

Required skills

• Electronic document management systems (e.g., Veeva Vault).
• Promotional review platforms (e.g., Veeva Vault).

What we offer

• Salary range $150,000‑$170,000 plus short‑term and long‑term incentive programs.
• Comprehensive benefits including medical, dental, vision, unlimited sick and flex time, 401(k), life and disability insurance.
• Recognition programs and a flexible work environment (remote considered for the right candidate).