Director US Advertising and Promotion Global Regulatory Affairs

Location: Morristown, NJ or Cambridge, MA

As the Director, US Advertising and Promotion, Global Regulatory Affairs within our GRA Advertising and Promo Team, you will be responsible for decisions, providing strategic direction and oversight for the day-to-day activities for assigned products. Ready to get started?

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

In this role, the candidate will serve as the resident expert in GRA US Advertising and Promotion (A&P) group on promotion, labeling, product defense, and development strategies for assigned product(s). The Director is responsible for decision‑making, direction, and oversight of the day‑to‑day activities of their assigned products, departmental activities, and direct reports (if applicable) in order to meet internal and external customer needs.

Develops and implements regulatory strategies for marketed products within their product area. Provides input into the global organization for labeling strategies of marketed and pipeline products. Demonstrates significant autonomy in carrying out assigned duties and responsibilities. Liaises with FDA regarding product promotion matters.

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

• Makes decisions, provides strategic direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports (if applicable).

• In conjunction with the US A&P Therapeutic Area Head, develops effective regulatory strategies regarding product promotion and imparts senior regulatory guidance and advice during issues management activities.

• Continually monitors the regulatory environment, interprets new regulations, guidance documents, and enforcement activities/trends and evaluates the impact on the business.

• Mentors and develops the professional expertise of US A&P staff in their product areas.

• Establishes and develops key internal relationships with therapeutic product leaders in Commercial organization, R&D and Corporate functions (e.g., Communications, Compliance, Legal) to foster open communication and teamwork.

• Assures alignment and consistency in US A&P policy application within and across assigned products; takes into account the totality of product-related and company activities.

• Establishes and maintains strong relationships with relevant FDA staff.

• Performs other duties as assigned.

• Bachelor’s degree from an accredited four-year college or university;
  Science focus preferred, but not required.

• Experience with in pharmaceutical or medical device Regulatory Affairs.

• Successful track record with 8+ years relevant regulatory experience.

• Experience in Advertising and Promotion in Regulatory required

• Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.

• Experience managing others preferred.

• Regularly demonstrates the ability to participate in a more strategic capacity in the functional area and day-to-day decision making process.

• Extensive knowledge and…