Associate Director, Regulatory Affairs

Kenvue is currently recruiting for Associate Director, Regulatory Affairs. 

Kenvue is recruiting for an Associate Director, Regulatory Affair for their R&D organization, 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, or Skillman, NJ (anticipated move to Summit, NJ). 

Who We Are 

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. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of 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.

Watch us here.

What will you do   

Key Responsibilities-

This position resides within the R&D organization, Regulatory Affairs function, and will report into the Director, Regulatory Affairs. The Associate Director, 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 

• Provide strong Regulatory leadership in the creation of robust regulatory strategies, impact assessments and risk management plans that drive timely approvals and product launches, and that drive achievement of priority US market and Global expansion roles.
• Leads activities concerned with the submission and approval of products to government regulatory agencies. Leads meetings and interactions with FDA taking into account enterprise-wide objectives and ensuring that meeting objectives are met and the strong reputation of the Company is maintained.
• Leads Regulatory activities for innovative and marketed products across other Regulatory classifications (eg, dietary supplements, devices)
• Provides guidance to project team members regarding regulatory compliance issues. Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new drugs and regulatory support of marketed drugs and other products.
• Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters.
• Leads US strategy development and timely execution of Pain priorities
• Drive collaboration within R&D and with cross functional partners to develop robust and innovation claims supported with science. 
• Responsible for providing guidance regarding regulatory compliance in the development of claims for new and existing issues and products. 
• Partners with Legal, Medical and Commercial leadership to align on risk and communicate that appropriately, updating the project risk assessment based on evolving external environment
• People leadership and cultivating talent - Oversees priorities within Regulatory Affairs Pain Franchise.  Works closely with team on development plans and career planning
• Engages in multiple project types and workstreams (New Product Development, Life Cycle Management, compliance initiatives, business process improvement opportunities), providing US RA Subject Matter Expert guidance and input from a Self-Care perspective
• Using knowledge of Regulatory landscape, competitive benchmarking, external factors to shape and inform regulatory strategy.  Participates in industry association topics and committees (e.g. CHPA) to provide input to intelligence/policy initiatives in alignment with internal and external stakeholders.
• Acts as Regulatory lead on the Promotional Review Committee, responsible for the review and approval of promotional and educational materials. Develops, reviews, and approves OTC product labeling.
• 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.

What we are looking for  

       Required Qualifications  

• Bachelor's Degree in a Science-related discipline is required. 
• 7 years of experience of experience in Consumer, Pharmaceutical, Bio-Technology, or Life Sciences is required. 
• 5 years  of specific focus in Regulatory is required.
• Strong technical experience with US FDA regulations for Cosmetics and OTC Monograph and new drug applications (NDA ) drugs is required
• Experience in developing and executing Regulatory strategies is required.
• Excellent communication, collaboration, and leadership skills is required.
• Experience of successfully contributing to or leading product submissions and meetings with Health Authorities is required
• 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 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.
• Ability to travel up to 15% to local sites in the area, as well as other locations based on business needs is required

       Desired Qualifications 

• An advanced degree (Masters, PhD, PharmD, etc) is preferred.
• Knowledge of global health authority regulations for drugs is preferred.
• Experience working with industry counterparts and trade association committees and task groups is preferred.
• experience with Rx to OTC switch process, dietary supplement,  medical devices and combination products is preferred
• Regulatory Affairs Certification (RAC) 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 $131,000 to $225,000.

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. 

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