US Regulatory Affairs Lead for Personal Care Brands and Unisom – Gold Bond, Cortizone-10, Selsun Blue, ACT Mouthwash and Unisom Dietary supplements, OTC drugs

• Location: Bridgewater, NJ (Hybrid)

• Job type: Full time

About the job

At Sanofi Consumer Healthcare , we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”.

Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”.

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 strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

Our Team:

We’re immediately hiring a US Regulatory Affairs Lead for Personal Care and Sleep who is proficient in cosmetics, dietary supplements, and OTC products.

If you’re a strong leader who collaborates effectively within cross-functional teams from ideation to post-launch phases, apply now!

• Responsible for leading regulatory efforts for our Personal Care Brands (Gold Bond, Cortizone-10, ACT mouthwash, and Selsun Blue) and our sleep brand (Unisom) in NA Consumer Healthcare, covering dietary supplements, OTC, and NDA products.

• Accountable for representing regulatory functions for the mentioned brands to approve promotional material.

• Tasked with providing regulatory leadership for regional projects focused on sustainability and clean ingredients.

• Charged with ensuring compliance for existing business, new innovation projects (both internal and external development), and potential M&A opportunities.

• Comfortable operating in a matrix environment, adept at navigating ambiguity to drive decision-making across regional teams.

Main responsibilities:

• Work with other regulatory leads on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy, FDA engagement, labeling and advertising

• Work with cross functional teams to ensure that our sustainability & clean ingredient projects and initiatives are represented and establishing external advocacy

• Ensure effective execution for new innovative consumer-centric products and the life cycle management of products in the portfolio across the following regulatory classes (OTC monograph drugs, dietary supplements, cosmetics, foods and medical devices)

• Responsible for regulatory approval and maintenance of all product claims compendia for the personal care category and Unisom sleep.

• Knowledge of personal care products, dietary supplements, OTC products and NDA

• Ensure that all documents to be submitted to regulators represent the CHC aligned strategy, are complete, accurate, compliant with global and/or local submission standards and are organized in a manner to facilitate agency review

About you

• Minimum B.S.; M.S., Pharm D, MD, PhD or equivalent, preferred

• Regulatory Certification (RAC) preferred

• Minimum 5 years in Regulatory Affairs, including leadership roles

• Established experience supporting Personal Care and OTC products

• Deep and broad knowledge of regulatory requirements to support Personal Care product development and life-cycle management and all sleep formats

• Experience in promotional material approval

• Ideally, experience in Consumer Healthcare

• Effective collaboration

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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.

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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !