Manager Regulatory Affairs Advertising and Promotion

Sanofi; Massachusetts; Híbrido; USD 140 000 - 190 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health benefits

14 weeks gender-neutral parental leave

Wellbeing programs

Resumo da oferta

Sanofi in Cambridge, MA is seeking a Manager Regulatory Affairs Advertising and Promotion to lead regulatory strategy for US labeling, advertising and promotional materials. You will partner with medical, legal and commercial teams to ensure compliant, timely submissions and robust risk/benefit assessments across products.

The role emphasizes cross-functional leadership, strategic thinking, and a strong foundation in US FDA regulations.

Qualificações

• Bachelor’s degree in a science field is required.
• 1+ years in pharmaceutical or medical device Regulatory Affairs with Advertising and Promotion experience.
• Experience collaborating with cross-functional groups (Medical, Legal, Marketing, etc.).

Responsabilidades

• Identify A&P issues and collaborate with teams to implement solutions.
• Advise on risk/benefit of strategies and support sound business decisions on regulatory matters.
• Oversee regulatory strategic objectives and projects with minimal supervision.
• Represent Regulatory on brand teams and Committees for promotional materials.
• Provide input to optimize labeling and regulatory strategies for life-cycle management.

Conhecimentos

Regulatory affairs

Cross-functional teamwork

Oral and written communication

US pharmaceutical marketplace

Ethics and integrity

Formação académica

Bachelor's degree (Science)

Descrição da oferta de emprego

Job title: Manager Regulatory Affairs Advertising and Promotion

• Location: Cambridge, MA / Morristown, NJ

About the job

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

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. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

• Identifies product-specific or therapeutic area 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.
• Contribute 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.

About You

Basic Qualifications:

• Bachelor’s degree from an accredited four-year college or university; Science focus preferred, but not require

Work Experience Required:

• 1+ Years experience in the following areas:
  • Experience within pharmaceutical or medical device Regulatory Affairs.
  • Successful track record with ideally 1-3 years relevant regulatory experience.
  • Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
• Experience in Advertising and Promotion in Regulatory required.
• Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.

Knowledge, Skills and Equivalent Experience:

• Knowledge and understanding of complex medical and scientific subject matter.
• Ability to work well within cross-functional teams.
• Demonstrates solid oral communication and writing skills.
• Understanding of the U.S. pharmaceutical marketplace, 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.
• Develops and proposes 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 to gain acceptance of ideas or plans.
• Can build collaborative internal networks to obtain cooperation.
• Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values.
• Is able to balance 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 manage workload. Is able to multi-task 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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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.