Skip to main content
Two women in white lab coats look at a computer screen together

Regulatory Compliance and Operations Lead, NA

Morristown, New Jersey Permanent Date posted 05/07/2024
Apply now

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.

#GD-SA

#LI-SA

Apply Now
  • You have not viewed any jobs yet.

  • You have not saved any jobs yet.

Woman in lab looking at vial through magnifying goggles

Sanofi careers in the US

Join our US team and get expert mentorship and training platforms, while helping to shape our culture. Bring your passion and energy and use your skills to help create vaccines and medicines that halve the time from discovery to therapy.

Illustration of map pins on globe

Find out more about this location

Experience possibility

  • Your Saved Jobs

    Learn more
  • Cambridge Crossing

    We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.

    Learn more
  • Innovation in Action

    Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.

    Learn more
  • Sustainable and Green

    Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.

    Learn more
  • Sanofi’s AI Centre of Excellence in Toronto

    The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.

    Learn more
  • Ama

    Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.

    Learn more
  • Sanofi Canada's Philanthropic Efforts

    By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.

    Learn more
  • Emmanuel

    Emmanuel, Head of the Sanofi Digital Accelerator, shares how his team builds digital solutions that enable patients to receive new treatments to help improve their lives.

    Learn more
  • Dimitrije

    Dimitrije shares insights into the work carried out by the AI Centre of Excellence in Toronto.

    Learn more
  • Ziv

    Read Ziv's first-hand account describing the reasons he chose to join Sanofi – and many of the reasons why he now chooses to stay.

    Learn more
  • When you grow, we all grow

    We strive to support your whole self with thoughtfully crafted rewards that benefit you physically, financially, mentally and socially. Whatever your role, you'll thrive in our inclusive teams.

    Learn more
  • Build a career with purpose

    Bring your passion to your role and impact millions of people around the world. You're in the driver's seat – just set your goals, and we'll provide the training and support that will get you there.

    Learn more
  • Bolder, better futures

    Change your life. And the lives of millions around the globe. How? By starting a career where you're supported to grow, while having a tangible impact and learning from the best.

    Learn more
  • Our locations

    We're in 60+ countries, all pulling together to define the future of healthcare. Wherever you work, you'll develop your career alongside experts, using technology to chase bigger breakthroughs.

    Learn more
  • Sanofi Stories

    At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.

    Learn more
  • Sanofi at Cambridge Crossing

    Dubbed Sanofi at Cambridge Crossing, our new state-of-the-art facility will create an innovation hub promoting close collaboration and integration among business units. Join us and become part of a team dedicated to chasing the miracles of science that improve people’s lives.

    Learn more
  • Why Sanofi

    Get access to the tools, training, and support to reach your goals. By fulfilling your potential, you’ll help us achieve our aim of halving the time from discovery to therapy.

    Learn more
  • Our people & culture

    We're the first in Pharma to have a DE&I board. We also have Employee Resource Groups that create spaces for every Sanofian to be heard. Your voice matters – use it to shape our future.

    Learn more
  • Sanofi's Postdoctoral Program

    Designed for high-caliber Ph.D. graduates, Sanofi's Postdoctoral Program helps you advance your scientific career in a state-of-the-art environment.

    Learn more
  • Physician Careers at Sanofi

    At Sanofi, physicians like you have the opportunity to collaborate on new ideas and challenge established thinking. Learn about Physician careers here.

    Learn more
  • AI Centre of Excellence

    The AI Centre of Excellence at Sanofi is a unique data-driven team based in Downtown Toronto. We pride ourselves on being data-obsessed and highly focused on using state-of-the-art technologies to drive global impact.

    Learn more
Two women, seated in an office lobby, working on laptops and talking

What could we achieve together?

Want to join our Global Talent Community? Every Sanofian works on projects that truly make a difference to people’s lives.

What could you achieve? Sign up today and discover our latest opportunities as soon as they’re available.