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.

• 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.
  

• 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.
  

• 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