Science Lead for Rx to OTC Switches

Neuilly-sur-Seine (France) or Morristown (US)

About the job

At Sanofi, we’re committed to providing the next-gen healthcare that patients and customers need. It’s about harnessing data insights and leveraging AI responsibly to search deeper and solve sooner than ever before. Join our Global Switch Sciences team as Science Lead for Rx to OTC Switches​ and you can help make it happen. Your job? Inspiring professional who will leverage your regulatory and/or medical and or switch science experience and commercial awareness to proactively lead switch programs with the aim of contributing to Sanofi Consumer Healthcare business growth.

At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.

Main responsibilities:

• Oversees, entire switch program and associated work streams involved

• Oversees budget and timeline in association with project management

• Provide switch science leadership to deliver against key switch milestones and within budget

• Input into both project timelines, project success assessments and forward-looking costed proposals to support switch activity and lead team in well-thought-out decision making on strategies

• Proactively help to drive the business by looking at ways to deliver the switch programs in a time efficient manner whilst meeting financial spend estimates

• Lead external partner interactions and engagement with the cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy,

• Ensure that all documents to be submitted to regulators represent the CHC aligned strategy, are complete, accurate, compliant with global and/or local submission standards and are organized in a manner to facilitate agency review.

• Provide leadership and strategic engagement with FDA on switch development programs.  Consults with other markets/regions, as needed, on their strategies regarding Regulatory Agency interactions for switch-related projects.

• Provide leadership for the switch strategy and intelligence for due diligence and business development initiatives.

• Serve as a switch science educational resource to both internal and external customers.

• Work with various key switch functions at all levels to support the business unit objectives. This could include leading more than one switch program depending on business need.

About you

• Minimum B.S., M.S., Pharm D, MD, PhD or equivalent preferred

• Minimum 8-10 years in Regulatory/Medical Affairs or Switch Science including leadership roles.

• Minimum 5 years “de novo” switch experience with a track level of delivery

• Clear understanding of the regulatory/medical processes in the markets of interests and can support these with confidence and professionalism

• Experience in OTC switch in the markets of interest globally is preferred

• Experience with the US switch approval process with a demonstratable track record of delivering Label Comprehension, Self Selection and Actual Use studies to support switch programs

• Demonstrated success in completing key switch milestones in OTC environments; possesses a strong knowledge of the regulatory/medical requirements across the target markets

• Related experience with FDA meetings and negotiations regarding switch programs

• Fluent English required, additional languages desirable

• Recognized expert in managing direct reports and matrix teams and partnering with cross functional teams at a highly strategic level

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.

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com