Global Switch Science Lead (ACNU)

Global Switch Science Lead (ACNU)

• Location: Morristown, NJ/Hybrid

About the job

Are you ready to shape the future of Consumer Health? Your skills could be critical in helping our teams accelerate progress. Join our Global Switch Science Lead  where you will be responsible for leading the switch development program to approval of an assigned Rx-OTC Switch asset in target market. In addition, leads the development and implementation of an additional condition for nonprescription use (ACNU) for Rx-OTC switch that requires ACNU.  

This role involves developing and executing program strategies for global programs, interacting with cross-functional teams, and collaborating with internal and key external stakeholders. The individual will manage regulatory experts as direct report. Works closely with the Global Commercial Lead.

The ideal candidate is an experienced leader, who has a deep understanding of the Rx-OTC switch requirements and regulatory approval process, strong leadership skills, and a history of successful switch programs.

Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market. 

We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.

That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core.

Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands. 

This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers.

We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification.

Join us on our mission. Health. In your hands.

Main responsibilities:

• Oversee Switch Science Program – Manage the entire switch science program and associated work streams, including direct reports and matrixed colleagues, to ensure delivery of key switch priorities.

• Budget and Timeline Management – Oversee budget and timelines in collaboration with project management to deliver switch milestones on time and within financial targets.

• Regulatory Submission Oversight – Ensure that all development and registration dossiers submitted to Health Authorities align with the program strategy, meet regulatory requirements, and facilitate efficient review processes. Lead the development of regulatory interaction strategies.

• Business and Process Optimization – Proactively identify ways to drive efficiency in switch program delivery, ensuring timelines and budgets are met without compromising quality or compliance.

• Stakeholder and Partner Engagement – Represent the science team in alliance partner meetings and lead external partner interactions to address both strategic and tactical product issues. Collaborate cross-functionally with R&D, regulatory, safety, and commercial teams to drive switch program success.

• Rx-to-OTC Switch and ACNU Leadership – Lead the development and implementation of Additional Conditions of Nonprescription Use (ACNU) for switch programs in compliance with regulatory requirements. Provide innovative guidance on ACNU implementation in both the development and commercial phases.

• Regulatory Innovation and Education – Provide leadership on innovative regulatory strategies, including cybersecurity measures, and serve as an educational resource on Rx-to-OTC switch science for internal and external stakeholders.

About you

• Extensive Industry Experience – 15+ years of relevant experience, including at least 5 years of experience leading Rx-to-OTC switch programs with a proven track record of delivering key switch milestones.

• Regulatory and Medical Knowledge – Strong understanding of regulatory and medical requirements across global and regional markets, ensuring compliance with local regulations.

• Switch Product Expertise – Experience in clinical and consumer studies relevant to switch programs, with a focus on product development, registration, and market entry.

• Drug-Device Combination Products – Experience with drug-device combination product approvals (e.g., diagnostics, software medical devices), with a working knowledge of FDA guidelines, HIPAA requirements, and medical devic