Senior Regulatory Lead, Advertising & Promotion (FDA)

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

Benefits offered by this job

Incentive programs (ST/LT)

Comprehensive benefits package

Job summary

Servier in the U.S. is a Boston-based biopharmaceutical company focused on advancing science and patient-centric strategies.

The Senior Manager, Regulatory Affairs Advertising and Promotion will partner with Marketing, Medical Affairs, and Legal to ensure compliant, scientifically grounded messaging and oversee FDA OPDP submissions. The role leads day-to-day regulatory review of ads and promotional materials, guides conference activities, and supports product launches, with up to 10% travel and

Qualifications

• Bachelor’s degree in a scientific or healthcare field required.
• 5+ years in Regulatory Affairs, 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.

Responsibilities

• Lead the 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 a regulatory representative on the Promotional Review Committee (PRC) and MSRC for assigned products.
• Collaborate cross-functionally to develop product messaging based on clinical data.
• Oversee the preparation and timely submission of FDA Form 2253 for assigned US promotional materials.
• Provide strategic guidance on conference exhibit activities, speaker programs, and digital communication strategies.
• Monitor FDA enforcement actions to perform impact analysis for internal stakeholders.
• Support the Director in managing formal communications and regulatory notifications to FDA.
• Facilitate the development and implementation of SOPs for the promotional review process and local regulatory affairs responsibilities.
• Maintain regulatory documentation and correspondence tracking systems to ensure audit readiness and compliance.

Education

Bachelor’s degree in a scientific or healthcare field

Tools

Veeva Vault

Job description

Servier in the U.S. is a Boston-based biopharmaceutical company focused on advancing science and patient-centric strategies.

The Senior Manager, Regulatory Affairs Advertising and Promotion will partner with Marketing, Medical Affairs, and Legal to ensure compliant, scientifically grounded messaging and oversee FDA OPDP submissions. The role leads day-to-day regulatory review of ads and promotional materials, guides conference activities, and supports product launches, with up to 10% travel and