Senior Manager, Regulatory Affairs, Advertising and Promotion
Boston, Massachusetts, United States · Remote OK
$150k–$170k/yr
Senior
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 …
Skills: Regulatory affairs, Advertising and promotion, FDA regulations, OPDP guidance, Promotional review committee
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Senior Manager, Regulatory Affairs, Advertising and Promotion
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$150k–$170k/yr
Full-time
bachelor degree
Medical, Dental, Vision, Flexible time off, 401(k), Life insurance
Posted 16d ago
~40 hrs/week
Remote in Boston, Massachusetts, United States
Responsibilities
The Senior Manager leads the regulatory review of advertising, promotional, and educational materials to ensure compliance with FDA regulations. They act as a strategic partner to cross-functional teams and oversee submissions to the FDA Office of Prescription Drug Promotion.
Requirements
Candidates must possess a bachelor's degree in a scientific or healthcare field and at least 5 years of professional experience in regulatory affairs within the biotech or pharmaceutical industry. Strong expertise in FDA regulations and proficiency with electronic document management systems like Veeva Vault are required.
Full job description
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.
Related keywords
Regulatory AffairsAdvertising and PromotionBiopharmaceuticalFDAOPDPPRCMSRCVeeva VaultOncologyRare DiseaseComplianceClinical Study ReportsForm 2253Strategic MessagingBiotechPharmaceutical
Servier Pharmaceuticals is a Boston-based, commercial-stage biopharmaceutical company. As the U.S. subsidiary of Servier Group, Servier is governed by a non-profit foundation, enabling the company to approach innovation with a long-term vision centered on the patient, free of influence from outside investors and short-term market pressures.
Launched in the U.S. in 2018, Servier Pharmaceuticals is focused on advancing innovative therapies in oncology and neurology for patients living with difficult-to-treat diseases. In oncology, the company has built a portfolio of first- and best-in-class medicines designed to bring transformative precision therapies to more patients. Servier is expanding its neurology business with the same commitment to science, partnership, and patient-focused innovation.
At Servier, we bring the patient voice into everything we do. We are dedicated to advancing meaningful therapeutic progress and improving outcomes for the patients and communities we serve.
Offices: 200 Pier Four Boulevard, Boston , MA 02210, US
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