Regulatory Affairs Manager

About Servier

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. 

Role Summary

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.

Primary Responsibilities

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

Education and Required Skills

• 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

Travel and Location

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

Job Description

Candidate Profile

Servier’s Commitment

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.

Salary Range

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 competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements).  For more information on our benefits, please visit this link.