Job title: Director, US Advertising and Promotion, Global Regulatory Affairs
- Location: Morristown, NJ or Cambridge, MA
About the job: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.
Main 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.
About YouBasic Qualifications:- 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.
- 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 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.
Why Choose Us? - Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
The salary range for this position is:
$178,500.00 - $257,833.33
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.
