Director, US Advertising and Promotion, Global Regulatory Affairs

Sanofi•Morristown, NJ

1d•Onsite

About The Position

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. 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. 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.

Requirements

Bachelor’s degree from an accredited four-year college or university; Science focus preferred, but not required
Experience within 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.
Extensive knowledge and understanding of complex medical and scientific subject matter
Ability to work well within cross-functional teams
Can demonstrate solid oral communication and writing skills
Understanding of the U.S. pharmaceutical market place 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.
Develops collaborative relationships to facilitate the accomplishment of work goals
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
Can build networks to obtain cooperation without relying on authority
Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values
Is capable of managing product support projects on topics specific to the functional area.
Is able to balance managing these projects with day-to-day duties, ensuring participation from other members of the department as needed.
Is 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

Nice To Haves

Experience managing others preferred

Responsibilities

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