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 ... more details
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.
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:
- 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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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.
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