Instagram
youtube
Facebook

Director, Us Regulatory Affairs - Advertising And Promotion (Hybrid)

8+ years
USD 172,500.00 - 249,166.66
10 Oct. 28, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director, US Regulatory Affairs – Advertising and Promotion (Hybrid)

📍 Locations:

  • Cambridge, Massachusetts, USA

  • Morristown, New Jersey, USA

💰 Salary Range: USD 172,500.00 – 249,166.66

🏢 Company: Sanofi


About Sanofi

At Sanofi, we are an innovative global healthcare company driven by one purpose — to chase the miracles of science to improve people’s lives.
From oncology and rare diseases to neurology and vaccines, Sanofi teams work at the intersection of lab science and AI-powered discovery. Collaboration and curiosity are at the heart of our mission to turn breakthrough ideas into real-world impact.


About the Role

The Director, US Regulatory Affairs – Advertising and Promotion will serve as a subject matter expert (SME) on regulatory guidance related to U.S. promotional materials and communications.
You will partner cross-functionally with medical, legal, and marketing teams to ensure compliance with U.S. FDA regulations and industry standards. This is an individual contributor role with strategic leadership and mentoring responsibilities, though no direct reports.


Key Responsibilities

  • Provide expert regulatory oversight for promotional and advertising materials across assigned therapeutic areas.

  • Partner with cross-functional teams to ensure all communications comply with FDA and OPDP regulations, company policies, and industry standards.

  • Serve as a strategic advisor for regulatory advertising and promotion (Ad/Promo) matters.

  • Support the Sr. Director/Product Support Head by delivering senior regulatory guidance during issue management or rapid-response situations.

  • Monitor and interpret new U.S. regulations, FDA guidance, and enforcement trends to evaluate business impact.

  • Develop and execute regulatory strategies for marketed products, mentoring others on implementation.

  • Build effective partnerships with internal product leaders to foster teamwork and alignment.

  • Ensure consistency in policy interpretation and application across therapeutic areas.

  • Support regulatory interactions with the FDA and contribute to global labeling strategies.

  • Demonstrate independent decision-making and leadership in complex regulatory matters.


Qualifications & Experience

Education:

  • Bachelor’s degree (required) in Life Sciences or a related discipline.

  • Advanced degree (preferred): MSc, PharmD, PhD, MD, or JD.

Experience:

  • 8+ years of experience in Regulatory Affairs within the pharmaceutical or medical device industry.

  • Minimum 5 years of specialized experience in Advertising & Promotion (Ad/Promo) functions.

  • Strong background in interpreting complex medical/scientific data and regulatory requirements.

  • Proven ability to collaborate with cross-functional teams (Medical, Legal, Marketing, etc.).

  • Prior leadership, mentoring, or training experience within regulatory or Ad/Promo preferred.


Core Skills

  • Deep understanding of the U.S. pharmaceutical marketplace and FDA promotional regulations.

  • Excellent strategic thinking, problem-solving, and decision-making abilities.

  • Strong negotiation and influencing skills across departments and stakeholders.

  • Exceptional oral and written communication skills.

  • Capable of managing multiple projects and tight timelines effectively.

  • High level of professional integrity and accuracy in presenting information.

  • Ability to foster collaboration and innovation in cross-functional environments.


Why Choose Sanofi

🌟 Purpose & Impact: Work at the forefront of science to improve global health outcomes.
🚀 Career Growth: Explore countless opportunities for promotion, mobility, and leadership development.
💼 Rewards & Benefits:

  • Comprehensive healthcare coverage

  • Wellness and prevention programs

  • At least 14 weeks of gender-neutral parental leave
    🤝 Culture: Inclusive, diverse, and future-focused environment where every voice is valued.


Equal Opportunity Statement

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action Employers committed to cultural diversity and inclusion.
All qualified applicants will receive consideration for employment without discrimination based on race, color, religion, gender, national origin, sexual orientation, age, disability, veteran status, or any legally protected characteristic.


Quick Facts

🧭 Department: Regulatory Affairs
📢 Focus Area: U.S. Advertising & Promotion Compliance
🏢 Work Type: Hybrid (Cambridge, MA / Morristown, NJ)
📊 Job Category: Regulatory Affairs / Drug Promotion Compliance
🌍 Therapeutic Areas: Immunology, Oncology, Rare Diseases, Neurology, Vaccines


Join Us

Pursue Progress. Discover Extraordinary.
Join Sanofi and help shape a new era in medicine — where your expertise drives innovation, and your career grows alongside global impact.