Senior Manager, Regulatory Affairs, Advertising and Promotion

SERVIER MONDE•Boston, MA

8d•$150,000 - $170,000•Hybrid

About The Position

The Senior Manager, Regulatory Affairs Advertising and Promotion at Servier Pharmaceuticals will report to the Director of US Regulatory Affairs and Quality Management and is responsible for leading the day-to-day regulatory review of advertising, promotional, and educational materials. This role acts as a strategic partner to Marketing, Medical Affairs, and Legal, ensuring that company objectives are achieved through compliant and scientifically grounded messaging. You will contribute to the success of both marketed products and pipeline candidates as well as oversee submissions to the FDA Office of Prescription Drug Promotion (OPDP). This position offers a unique opportunity to help shape the regulatory framework of a growing, patient-centric organization.

Requirements

Bachelor’s degree in a scientific or healthcare field required
5+ years of professional experience in Regulatory Affairs, specifically within advertising and promotion in a biotech/pharmaceutical setting (Oncology and Rare Disease preferred)
Strong expertise in FDA regulations and guidance documents
Proficiency with electronic document management systems and promotional review platforms such as Veeva Vault
Demonstrated ability to interpret complex clinical study reports and translate data into compliant promotional messaging and solutions
Excellent interpersonal and influence skills to navigate cross-functional stakeholder requirements
High level of organizational skills with the experience managing product launches
Proactive critical thinking skills with a solutions-oriented approach

Nice To Haves

Oncology and Rare Disease experience preferred

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 key regulatory representative on the Promotional Review Committee (PRC) and Medical Scientific Review Committee (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 standard operating procedures for the promotional review process and local regulatory affairs responsibilities
Maintain regulatory documentation and correspondence tracking systems to ensure audit readiness and compliance