Senior Manager, Regulatory Affairs Advertising and Promotion

As the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and Promo Team, you will conduct the independent review of advertising, promotional, communications, and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns.

About Sanofi

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.

Responsibilities

• Identifies product-specific or therapeutic area advertising and promotion (A&P) issues and works with other teams to propose and implement solutions.
• Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters.
• Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision.
• Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.
• Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement.
• Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs.
• Contributes A&P expertise to the development of optimal labeling on new and supplemental new drug applications.
• Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders.
• Performs other duties as assigned.

Requirements

• Bachelor’s degree in Life Sciences from an accredited four-year college or university.
• 3+ years of experience within pharmaceutical or medical device advertising and promotional review.
• Successful track record with ideally 1-3 years of relevant regulatory experience.
• Experience dealing effectively with cross-functional groups, which may include Medical, Legal, Marketing, etc.

Skills

• Knowledge and understanding of complex medical and scientific subject matter.
• Ability to work well within cross-functional teams.
• Solid oral communication and writing skills.
• Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology.
• Ability to analyze issues, problems, and opportunities by comparing data from different sources to draw conclusions and choose a course of action.
• Develops collaborative relationships to facilitate the accomplishment of work goals.
• Proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
• Uses appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.
• Builds collaborative internal networks to obtain cooperation.
• Unquestionable ethics, professional integrity, and personal values consistent with Sanofi values.
• Balances projects with day-to-day duties, ensuring participation from other members of the department as needed.
• Establishes priorities and timelines to effectively manage workload and multi-tasks well.
• Deals with people in an honest and forthright manner, representing information and data accurately.

Benefits

• Discover endless opportunities to grow your talent and drive your career, whether 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 of gender-neutral parental leave.