Regulatory Affairs, Self-Care Manager

Kenvue•Summit, NJ

2d•Hybrid

About The Position

Kenvue is currently recruiting for a: Regulatory Affairs, Self-Care Manager What we do At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information , click here . Role reports to: DIRECTOR REGULATORY AFFAIRS Location: North America, United States, New Jersey, Summit Work Location: Hybrid What you will do The Manager, Regulatory Affairs will have regulatory responsibility for products across needs-states including within the Pain Franchise (which includes key brands such as TYLENOL®, MOTRIN®, and BENGAY®); and for several products in development that include a wide range of Regulatory classifications (NDA/ANDA and Monograph Drugs, Dietary Supplements, Medical Devices and Combination products). The candidate will be the primary contact with the Food and Drug Administration for NDA/ANDA and Monograph Drug submissions.

Requirements

A minimum of a Bachelor’s Degree in a Science-related discipline.
A minimum of 5+ years of direct or indirect Regulatory Affairs experience in a highly regulated environment.
Experience with INDs, NDAs, and OTC monograph products and knowledge of the Rx-to-OTC switch process and ANDAs.
Experience in developing and executing Regulatory strategies.
Excellent communication, collaboration, and leadership skills.
Experience successfully contributing to or leading product submissions and meetings with Health Authorities.
Ability to interact with all internal departments and at all company levels, and within Kenvue Consumer and across company sectors, as well as with regulatory agencies, industry partners, contractors and service providers.
This job will be located in Summit NJ.
This position may require travel up to 15% to local sites in the area, as well as other locations based on business needs.

Nice To Haves

Experience with dietary supplement, medical devices and combination products.
Regulatory Affairs Certification (RAC)
Ability to partner with cross-functional teams including, Marketing, Medical, Legal, Clinical and Safety, with a demonstrated ability to combine research in regulations, precedent, and product design to develop and execute regulatory approval and claims strategies.

Responsibilities

Understand the Regulatory landscape for Consumer products and manage regulatory priorities, projects and activities for marketed products and will support and/or lead regulatory strategy for innovative projects.
Labeling, digital, promotional review and approval, as well as other project execution and post-market related activities.
Routine submissions to FDA, which may include preparing meeting requests and meeting background packages to FDA.
Support and/or lead FDA interactions and ensure that meeting objectives are met and ensure the strong reputation of the Company is maintained.
Strong leadership representing Regulatory on project teams providing expertise and alternatives to optimize strategy and claims, and/or in optimizing processes and/or systems related to regulatory activities.
Use knowledge of regulatory landscape, competitive benchmarking, external factors to shape and inform regulatory strategy.
Demonstrate successful collaboration and partnership across teams and functions within the organization.
Lead process improvement workstreams.
Monitor regulatory environment for new industry standards, FDA guidances, regulations, and draft legislation for impact to the business.
Work with industry association(s) to provide comments to draft guidance and to help shape regulatory policy.
Support and/or lead Regulatory activities for innovative and marketed products across other Regulatory classifications (eg, dietary supplements, devices)
Support external innovation due diligence activities and product development.