Senior Manager, Regulatory Affairs, Advertising and Promotion

Senior Manager, Regulatory Affairs, Advertising and Promotion

Type of

Contract:

Full-time Employment / Unlimited

Job Requisition

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision.

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.

Regulatory Affairs 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

• 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

• Up to 10% Travel
• Boston based preferred, but remote considered for the right candidate.

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

The salary range for this role is $150,000 - $170,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future.

Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a…