🌍 Job Title: Associate Director, Global Regulatory Affairs – Advertising & Promotion
🏢 Company: Sanofi
📍 Locations:
Cambridge, Massachusetts, USA
Morristown, New Jersey, USA
💰 Salary Range:
USD 147,000.00 – 212,333.33
🔬 About the Role
Are you ready to shape the future of medicine?
At Sanofi, we accelerate drug discovery and development to bring life-changing answers to patients and their families. As an Associate Director, Global Regulatory Affairs – Advertising & Promotion, you’ll be responsible for providing regulatory review and approval of U.S. promotional, product, and disease-related materials for assigned products.
You’ll act as the regulatory product expert, developing and implementing strategies that ensure compliance with FDA promotional guidelines and support Sanofi’s marketing and medical objectives.
🎯 Key Responsibilities
Regulatory Review & Compliance
Serve as the U.S. Regulatory Affairs (AdPromo) representative on cross-functional Brand and Review Committees (RCs).
Review and approve advertising, promotion, disease-state, market access, and press materials.
Submit materials to the FDA on Form 2253, as applicable.
Provide regulatory strategy for investigational and marketed products to align business goals while minimizing risk.
Offer input into FDA product labeling for NDAs and BLAs to optimize promotional compliance.
Liaison & Collaboration
Act as primary liaison with the FDA OPDP/APLB, managing regulatory communications effectively.
Build strong partnerships with internal stakeholders including Legal, Medical, Marketing, Communications, and Compliance.
Provide expert guidance to senior management and global teams on promotional regulatory issues.
Process Development & Leadership
Contribute to the creation, monitoring, and improvement of AdPromo-related standards and processes.
Stay current with evolving FDA regulations, industry guidance, and digital promotion trends.
Represent Sanofi at industry meetings and medical congresses to enhance knowledge and influence best practices.
🧩 About You
🎓 Education
Bachelor’s degree in Life Sciences or related field required.
💼 Experience
Minimum 1 year (3+ years preferred) of regulatory experience in pharmaceutical, biotech, or medical device industries.
Proven understanding of U.S. pharmaceutical promotion laws and FDA regulations.
Knowledge of digital and social media communication platforms required.
💡 Skills & Attributes
Strong grasp of medical and scientific subject matter.
Excellent communication skills (written and verbal).
Demonstrated ability to manage multiple projects, set priorities, and meet deadlines.
Collaborative mindset with the ability to influence across cross-functional teams.
Innovative problem solver with a proactive and adaptable approach.
🌟 Why Choose Sanofi?
Join a future-focused, innovative global healthcare leader.
Explore career growth opportunities through promotions or global mobility.
Access comprehensive health and wellbeing benefits, including:
Premium healthcare
Prevention and wellness programs
At least 14 weeks of gender-neutral parental leave
Inclusive and diverse work culture that celebrates individuality.
⚖️ Equal Opportunity Statement
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action Employers committed to a diverse workforce. All qualified applicants will receive consideration regardless of race, color, creed, religion, national origin, age, sex, gender identity, sexual orientation, disability, or veteran status.
📢 Additional Information
Work Mode: Onsite
Hashtags: #GD-SA #LI-SA #LI-Onsite #vhd
Compensation: Based on demonstrated experience
Benefits: Eligible for Sanofi employee programs and full benefits package
🚀 Join Us
At Sanofi, you’ll chase the miracles of science and help improve lives around the world. Your growth will be as transformative as the work you do. Together, let’s Pursue Progress and Discover Extraordinary.
🔗 Watch “One Day at Sanofi” and explore our Diversity, Equity & Inclusion initiatives at sanofi.com
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