Director, US Advertising and Promotion, Global Regulatory Affairs

Sanofi • Cambridge, MA

1d • $178,500 - $257,833 • Onsite

About The Position

The Director, US Advertising and Promotion, Global Regulatory Affairs will provide strategic direction and oversight for the day-to-day activities for assigned products within the GRA Advertising and Promo Team. This role serves as the resident expert in the 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 day-to-day activities for assigned products, departmental activities, and direct reports (if applicable) to meet internal and external customer needs. The role involves developing and implementing regulatory strategies for marketed products, providing input into global labeling strategies for marketed and pipeline products, and demonstrating significant autonomy. The Director will also liaise with the FDA regarding product promotion matters.

Requirements

• Bachelor’s degree from an accredited four-year college or university
• 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.
• 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

Nice To Haves

• Science focus for Bachelor's degree
• Experience managing others

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

Benefits

• Opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
• Rewards package that recognizes your contribution and amplifies your impact
• Wide range of health and wellbeing benefits including high-quality healthcare
• Prevention and wellness programs
• At least 14 weeks’ gender-neutral parental leave

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 11-50 employees