Regulatory Compliance and Operations Lead, NA

Regulatory Compliance and Operations Lead, NA

Location: Morristown, NJ

About the Job

Are you passionate about navigating the complex landscape of regulatory requirements? We have a great opportunity for a Regulatory Compliance and Operations Lead North America.  Join our team and play a pivotal role in shaping our regulatory strategy and ensuring compliance across all facets of our operations.

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:

• Optimize and oversee the tracking, execution and oversight for all necessary regulatory affairs licenses, including any in scope US/Canada/Puerto Rico federal, province and state licenses.

• Oversee the tracking, compilation and Sanofi CHC North America

• Regulatory Affairs review of US Annual Reports.

• Own the process and lead the planning, scheduling and execution of US FDA drug listings.

• Own the process and lead the planning, scheduling and execution of required product registrations in Puerto Rico.

• Ensure that NA Regulatory processes and systems are audit ready, including facilitating any inspection planning with the appropriate cross functional teams.

• Assist with internal, external and call center inquiries, including Country of Origin, Country of Manufacture, Trade Agreements Act affidavits, CRP and TSCA status, “Made in the USA” determinations, etc.

• Provide regulatory expertise on simplification of our processes & workflows in areas such as the labeling approval process within NA and Veeva Vault documentation.

• Deliver projects/other duties as required based on internal or external requirements for NA Regulatory Affairs.

• Support quality leads at manufacturing sites to ensure compliance in areas including Drug Enforcement Administration (DEA) and Pseudoephedrine (PSE) licenses & quota, State Boards of Pharmacy licenses, establishment registrations, etc.

About You

• B.S. required; M.S., PhD, PharmD

• 6-8 years regulated CHC industry experience across multiple regulatory classes (NDA, Monograph, Device, Cosmetic, Food, Dietary Supplement), with 3 years of direct regulatory compliance experience.

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.

• You will grow alongside a talented team motivated by a shared purpose

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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