Global Switch Regulatory Lead

Global Switch Regulatory Lead

• 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 Regulatory team as Global Switch Regulatory Lead where you will be is responsible for developing and executing the regulatory strategy of the switch development program to approval of an assigned Rx-to-OTC Switch asset in target market. The regulatory lead reports to the Global Switch Science Lead.

This role involves developing and executing regulatory program strategies for global programs, interacting with cross-functional teams, and collaborating with internal and key external stakeholders. Works closely with the Brand Lead.  The ideal candidate is an experienced leader, who has an understanding of the Rx-OTC switch requirements, software as medical device requirements, regulatory approval process and strong communication skills.

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:

• Lead the regulatory strategy and execution efforts working closely with science lead and the cross-functional teams for both new products/claims as a well as the future life cycle management of switch line extension opportunities including regulatory classes (drug, medical device, combination products).

• Lead the development and execution of the submission dossier and regulatory strategy for the NDA or other global regulatory submissions.

• Provide regulatory strategies, input and review for clinical and consumer studies (e.g. label comprehension study, self-selection study, actual use trial, human factors study, RWE study etc.), related to protocol, data collection instrument and study reports on different switch programs as needed.

• Drive and design the best regulatory strategy for the registration of switch candidates and respond to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products.

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

• Leads FDA interactions with cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy, digital innovative strategies, FDA submission, labeling and claims support.

• Works within Opella and externally across US Trade Associations to identify and solve for issues and strategic aligned opportunities to promote self-care.

• Responsible for making decisions and proposing solutions on new commercial strategies for Brand names, DTC, digital tech, retail tech, ecommerce, claims in line with regulatory requirements.

• Ensure current and proposed regulatory, scientific and pertinent legal issues including analysis of potential impact are made present to the business.

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

• Serves as an educational switch resource to both internal and external customers.

• Provide clear advice on future trends, competitive intelligence and emerging FDA requirements for development programs and help to drive innovation.

• Contributes to interdepartmental projects

• Proactively help to drive the business proposing solutions to both internal and external challenges, shaping the external switch regulatory environment.

About you

• Education: Minimum B.A./B.S. An advanced degree such as MS or equivalent preferred.  

• 8+ years of relevant regulatory experience, including switch roles.

• Regulatory Knowledge – possesses a strong knowledge of the regulatory requirements for Rx-to-OTC switches, registration dossier. Knowledge on software as medical devices, ACNU requirements or global regulatory experience is preferred.

• Recognized expert in partnering with cross functional teams at a strategic level.

• Strong ability to adapt to evolving business and regulatory environments, providing innovative solutions and strategic direction.

• Excellent written and verbal communication skills, with the ability to present complex information clearly and concisely to both internal and external stakeholders.

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.