Senior Manager, Regulatory Strategy for Ad & Promo

Servier; Boston (MA); Hybrid; USD 150,000 - 170,000; Full time

Job summary

Servier is seeking a Senior Manager, Regulatory Affairs, Advertising and Promotion in Boston. You will lead regulatory reviews of promotional materials, ensuring FDA compliance and accurate scientific messaging.

Collaborative role with Marketing, Medical Affairs, and Legal to support both marketed products and pipeline candidates. Responsibilities include submissions, committee representation, and strategic input on promotional programs, with travel up to 10%.

Qualifications

• Bachelor’s degree in a scientific or healthcare field required.
• 5+ years in Regulatory Affairs, specifically in advertising and promotion in biotech/pharma.
• Strong expertise in FDA regulations and guidance documents.
• Proficiency with electronic document management systems and promotional review platforms such as Veeva Vault.
• Ability to translate clinical data into compliant promotional messaging and solutions.

Responsibilities

• Lead regulatory review and approval of advertising, promotional, and disease state materials.
• Ensure all promotional initiatives comply with FDA regulations and OPDP guidance.
• Serve on PRC/MSRC for assigned products and interact cross-functionally with Marketing and Legal.
• Oversee submission and tracking of FDA Form 2253 for US promotional materials.
• Provide strategic guidance on conferences, speaker programs, and digital communications.
• Maintain audit-ready regulatory documentation and SOPs for promotional reviews.

Skills

FDA regulations

Regulatory submissions

Advertising & Promotion

Cross-functional collaboration

Clinical data interpretation

Education

Bachelor's degree in a scientific or healthcare field

Tools

Veeva Vault

Electronic document management systems

Job description

Servier is seeking a Senior Manager, Regulatory Affairs, Advertising and Promotion in Boston. You will lead regulatory reviews of promotional materials, ensuring FDA compliance and accurate scientific messaging.

Collaborative role with Marketing, Medical Affairs, and Legal to support both marketed products and pipeline candidates. Responsibilities include submissions, committee representation, and strategic input on promotional programs, with travel up to 10%.