Manager Regulatory Affairs Advertising and Promotion

Sanofi • Morristown, MA

1d • Hybrid

About The Position

The Manager of Regulatory Affairs Advertising and Promotion supports Sanofi’s regulatory strategy for advertising and promotional activities across products and therapeutic areas. The role identifies product-specific and therapeutic-area issues, develops potential approaches, advises on their risks and benefits, and works with stakeholders to implement solutions. The manager oversees regulatory strategic objectives and projects with minimal supervision and serves as a Regulatory representative on brand teams and review committees for commercial and medical materials.

The position provides regulatory guidance to commercial and R&D groups to support product development, promotion, advertising, reimbursement, and lifecycle management. It contributes advertising and promotion expertise to labeling for new and supplemental drug applications and develops product-specific strategies to mitigate risk and maximize value for stakeholders. The role is based in Cambridge, Massachusetts, or Morristown, New Jersey.

Requirements

• Bachelor’s degree from an accredited four-year college or university; a science focus is preferred but not required.
• At least 1 year of experience in pharmaceutical or medical device Regulatory Affairs.
• Experience in Regulatory Affairs Advertising and Promotion is required.
• Experience dealing effectively with cross-functional groups, potentially including Medical, Legal, and Marketing.
• Knowledge and understanding of complex medical and scientific subject matter.
• Ability to work well within cross-functional teams, communicate orally and in writing, and use medical terminology.
• Understanding of the U.S. pharmaceutical marketplace.
• Ability to analyze data from different sources, draw conclusions, and select an appropriate course of action or solution.
• Ability to develop collaborative relationships and internal networks to accomplish work goals and obtain cooperation.
• Ability to propose innovative solutions and use appropriate interpersonal approaches to gain acceptance of ideas or plans.
• Professional ethics, integrity, and personal values consistent with Sanofi values; represent information and data honestly and accurately.
• Ability to balance projects and day-to-day duties, establish priorities and timelines, and manage multiple tasks.

Nice To Haves

• Science-focused bachelor’s degree.
• Ideally 1–3 years of relevant regulatory experience.

Responsibilities

• Identify product-specific or therapeutic-area advertising and promotion issues and work with other teams to propose and implement solutions.
• Identify strategies for addressing issues, advise on their risks and benefits, and help clients make informed business decisions regarding regulatory matters.
• Oversee and take responsibility for successful implementation of regulatory strategic objectives and projects with minimal supervision.
• Participate actively as the Regulatory representative on brand teams and review committees for commercial and medical materials, respectively.
• Provide guidance and feedback to internal commercial and R&D groups to support competitive product development, promotion, advertising, and reimbursement.
• Provide input to the Global organization on domestic regulatory strategies for in-line products through lifecycle management programs.
• Contribute advertising and promotion expertise to the development of labeling for new and supplemental new drug applications.
• Develop product-specific regulatory strategies to mitigate risk and work with brand team management on advice and risk-benefit analysis.
• Perform other duties as assigned.

Benefits

• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Employee benefit programs may be available to eligible employees.
• Rewards package recognizing employee contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager