R&D
Where your curiosity drives the
miracles of
science

Job Title: Director, US Regulatory Affairs - Advertising and Promotion

Location: Cambridge, MA or Morristown, NJ

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

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

• In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and guidance for Rapid Response Teams; functions as the therapeutic product expert for Region NA, A&P.

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

• Develops and implements regulatory strategies for marketed products within their product area and mentor and develop others in executing strategy.

• Establishes and develops key internal relationships with therapeutic product leaders in R&D and Corporate to foster open communication and teamwork.

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

• Assists in ensuring product support relationships with FDA are established and maintained.

• Provides input into the global organization for labeling strategies of marketed drugs. Demonstrates significant autonomy in carrying out assigned duties and responsibilities.

About You

Experience:

• 8+ years of experience within pharmaceutical or medical device Regulatory Affairs

• Successful track record of relevant advertising & promotion regulatory experience

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

• Experience managing others is preferred

Education:

• Minimally, possess a Bachelor’s degree from an accredited four-year college or university in a relevant Life Sciences discipline or specialization

Additional Skills:

• Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.

• 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 understanding of complex medical and scientific subject matter.

• Can build networks to obtain cooperation without relying on authority. You will also have the ability to work well within cross-functional teams.

• Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.

• Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans.

• Able to establish priorities and timelines to effectively self-manage workload. Is able to multi-task exceptionally well.

• Deals with people in an honest and forthright manner representing information and data accurately. 

Why Choose Us?

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com