Therapeutic Area Head Global Labeling, Immunology Inflammation and Neurology

Job title: Therapeutic Area Head Global Labeling, Immunology Inflammation and Neurology

• Location: Bridgewater, NJ or Cambridge, MA

About the job

You will oversee Labeling Strategists and be directly responsible for the preparation of corporate, US and EU labeling (prescribing information, patient information and other labeling components) for Developmental and Life Cycle Management products in Sanofi's Immunology & Inflammation and Neurology Therapeutic Areas. The position reports to Head of Global Labeling Strategy at Sanofi.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities

• Develop innovative labeling strategies that support the safe and effective use of the products in assigned portfolio and meet the company's strategic objectives.
• Oversee and prepare developmental labeling for new products and Life-Cycle Management products based on study data, internal data, and labeling requirements worldwide resulting in internal and health authority approved product labeling including Corporate, US and EU labeling.
• Chairs multi-disciplinary labeling working groups, presenting labeling proposals and developing/reaching consensus on proposals resulting in presentation of labeling proposals to the Labeling Governance Committee for internal approval of proposed labeling.
• Effectively contributes to labeling negotiations with regulatory agencies resulting in approved labeling allowing marketing of the product.
• Oversee and prepares labeling for submission to regulatory agencies as part of Marketing Authorization Application or updates to Marketing Authorization Applications.
• Ensure that labeling strategists in Therapeutic Areas are current in their knowledge of regulatory requirements, competitor analyses and therapeutic area. Coaching and mentoring direct reports for skill enhancement and professional development.
• Build and maintain relationships with key stake holders in global regulatory affairs, other R&D and commercial functions to ensure alignment on labeling strategy.
• Lead and contribute to transversal initiatives as needed to improve processes, systems within the department. Brings a best practice mindset to build a best-in-class labeling organization.

About you

• Recognized Subject Matter Expert with knowledge of labeling requirements for drugs, drug-device combinations for US, EU, and other major global markets.
• Proven ability to lead and develop direct reports/labeling strategists in the organization.
• Expert knowledge of regulatory requirements in major markets pertaining to marketing authorization filings for new products or updates to existing products.
• Organizational and networking skills; and ability to coordinate discussions across all levels of the company to reach resolution on labeling topics.
• Advanced degree or higher in life science, pharmacy, medicine or medical related field.
• Minimum of 10 years’ experience in the pharmaceutical industry including regulatory affairs and labeling.
• Development product labeling experience is required.
• Experience in Immuno-inflammatory diseases and Neurology preferred.
• Experience managing multiple therapeutic areas is also preferred.

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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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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