Regulatory Affairs, Self-Care Manager

About the position reputed company is currently reputed company for a: Regulatory Affairs, Self-Care Manager reputed company do At reputed company, we realize the extraordinary power of everyday care. reputed company on over a century of heritage and rooted in science, we’re the house of reputed company 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 reputed company people with a workplace culture where every voice reputed company, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and reputed company, being a Kenvuer means having the power to reputed company millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have reputed company opportunities waiting for you! Join us in shaping our reputed company–and yours. For more information, click here. Role reports to: DIRECTOR REGULATORY AFFAIRS Location: reputed company, reputed company, New Jersey, reputed company Work Location: Hybrid What you will do The Manager, Regulatory Affairs will have regulatory responsibility for products across needs-states including reputed company the Pain Franchise (which includes key brands such as TYLENOL®, MOTRIN®, and BENGAY®); and for several products in development that include a wide reputed company 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, reputed company and activities for marketed products and will support and/or reputed company regulatory reputed company for innovative reputed company. • Labeling, digital, promotional review and approval, as reputed company as other project execution and post-market reputed company activities. • Routine submissions to FDA, which may include preparing meeting requests and meeting background packages to FDA. • Support and/or reputed company FDA interactions and ensure that meeting objectives are met and ensure the strong reputed company of reputed company is maintained. • Strong leadership representing Regulatory on project teams providing expertise and alternatives to optimize reputed company and claims, and/or in optimizing processes and/or systems reputed company to regulatory activities. • Use knowledge of regulatory landscape, competitive benchmarking, external factors to shape and inform regulatory reputed company. • Demonstrate successful collaboration and partnership across teams and functions reputed company the organization. • reputed company process improvement workstreams. • Monitor regulatory environment for new industry standards, FDA guidances, regulations, and draft legislation for reputed company to the business. • Work with industry association(s) to reputed company comments to draft guidance and to help shape regulatory policy. • Support and/or reputed company Regulatory activities for innovative and marketed products across other Regulatory classifications (eg, dietary supplements, devices) • Support external innovation due diligence activities and product development. • reputed company operates in a highly-regulated businesses environment. The Manager, Regulatory Affairs will champion behaviors that embody Our reputed company Values. Requirements • A minimum of a Bachelor’s Degree in a Science-reputed company discipline. • A minimum of 5+ years of reputed company 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 reputed company 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 reputed company with reputed company internal departments and at reputed company company reputed company, and reputed company reputed company Consumer and across company sectors, as reputed company as with regulatory agencies, industry partners, contractors and service providers. • This job will be located in reputed company NJ. • This position may require travel up to 15% to local sites in the area, as reputed company as other locations based on business needs. reputed company-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, reputed company, Clinical and Safety, with a demonstrated ability to combine research in regulations, precedent, and product design to reputed company and execute regulatory approval and claims strategies. Benefits • Competitive Benefit Package • reputed company Company Holidays, reputed company Vacation, Volunteer Time & More! • Learning & Development Opportunities • Kenvuer reputed company Networks Apply tot his job Apply To this Job