Regulatory Compliance and Operations Lead

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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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

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

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

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.