Manager, Regulatory Affairs - 2307013289W

　　DESCRIPTION/RESPONSIBILITIES:DescriptionKenvue is currently recruiting for Manager, Regulatory Affairs.

　　Kenvue is recruiting for an Manager, Regulatory Affairs for their Regulatory Affairs team. With our vision of being the world's best brand builders, our Consumer businesses are bringing BIG brand ideas to life through solutions and experiences that delight our consumers, create brand love and ultimately drive GROWTH.

　　This position will report into the Director, Regulatory Affairs based in Fort Washington, PA, USA or Skillman, NJ (with anticipated move to Summit, NJ).

　　What will you doKey Responsibilities-This position resides within the R&D organization, Regulatory Affairs function, and will report into the Director, Regulatory Affairs. 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

　　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 including Rx to OTC switch.* Kenvue operates in a highly-regulated businesses environment. The Associate Director, Regulatory Affairs will champion behaviors that embody Our Core Values

　　QualificationsWhat we are looking for* Required Qualifications* Bachelor's Degree in a Science-related discipline is required* 5 years of direct or indirect Regulatory Affairs experience in a highly regulated environment is required.* Experience with INDs, NDAs, and OTC monograph products and the Rx-to-OTC switch process and ANDAs is required.* Experience in developing and executing Regulatory strategies is required.* Excellent communication, collaboration, and leadership skills is required.* Experience successfully contributing to or leading product submissions and meetings with Health Authorities is required* 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 is required.* This po ition may require travel up to 15% to local sites in the area, as well as other locations based on business needs is required

　　Desired Qualifications* Experience with dietary supplement, medical devices and combination products is preferred.* Knowledge of global health authority regulations for drugs is preferred.* Regulatory Affairs Certification (RAC) is preferred* Ability to partner with cross-functional teams including Business Development, Marketing, Medical, 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 is preferred.

　　What's in it for you* Competitive Benefit Package* Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!* Learning & Development Opportunities* Employee Resource Groups* This list could vary based on location/region

　　The anticipated base pay range for this position is $97,000 to $145,000.

　　Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.