Global Regulatory Affairs CMC Lead, Influenza
Swiftwater, PennsylvaniaBridgewater, New Jersey
Morristown, Tennessee Permanent Date posted 14/06/2024
Job title:
- Location: Swiftwater, PA or Bridgewater/Morristown, NJ
About the Job
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:
As the Global Regulatory Affairs CMC Lead for Influenza, you will be responsible for the management and leadership of the regulatory aspects of influenza team.
Develop global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, and/or vaccine products) in collaboration with other parts of Global Regulatory Affairs.
Interpret global regulations & appropriately apply, implement, and communicate regulation, established or draft guidance's. Identify/recommend changes in regulations to strengthen company business approaches.
Provide leadership, regulatory expertise, regulatory strategy, and regulatory influence on projects and teams.
Identify regulatory opportunity and risk. Anticipate and communicate possible regulatory paradigm shifts that impact the company.
Identify, communicate, and manage resolution to regulatory CMC issues. Articulate the implication of issue to project team risk/benefit strategic component, ensuring consistency in approach.
Assures that appropriate contacts with Health Authorities, in collaboration with Country Regulatory Groups, are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships.
Responsible for direct contact/liaison with US FDA and EMA on specific CMC topics. Supports strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS).
Contributes knowledge and expertise on GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, in order to assure that appropriate Sanofi visibility and input is recognized.
Monitors the review of local and international Health Authority regulations and guidelines, contributes to the commenting process and/or develops position papers. Ensures that current Health Authority thinking and trends (paradigm shifts) are understood and broadly communicated.
About you
Five or more years managing an influenza portfolio
Demonstrated experience managing people and teams
Established Health Authority experience (US/Global)
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.
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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