Director, US A&P, Global Regulatory Affairs

Mass Digital Health; Cambridge (MA); On-site; USD 179,000 - 258,000; Full time

Job summary

Sanofi Inc. in the US seeks a Director of US Advertising and Promotion, Global Regulatory Affairs to provide strategic direction and oversight for day-to-day activities of assigned products.

You will lead regulatory strategies, liaise with FDA, and mentor staff across cross-functional teams to ensure compliant promotion and labeling. The role demands a strong background in Regulatory Affairs for pharma or medical devices, 8+ years of experience, and excellent communication.

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

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.

Skills

Regulatory Affairs

Advertising & Promotion

Cross-functional collaboration

Strategic thinking

Written & oral communication

Team leadership

FDA liaison

Education

Bachelor's degree

Job description

Sanofi Inc. in the US seeks a Director of US Advertising and Promotion, Global Regulatory Affairs to provide strategic direction and oversight for day-to-day activities of assigned products.

You will lead regulatory strategies, liaise with FDA, and mentor staff across cross-functional teams to ensure compliant promotion and labeling. The role demands a strong background in Regulatory Affairs for pharma or medical devices, 8+ years of experience, and excellent communication.