Associate Manager, Regulatory Affairs

Kenvue is currently recruiting for:
Associate Manager, Regulatory Affairs
This position reports to Director, Regulatory Affairs and is based in Skillman, 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® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the 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. For more information, click here.
Role reports to: AssociateDirector, Regulatory Affairs
Location: Skillman, NJ (Kenvue's corporate headquarters is currently located in Skillman NJ, but is scheduled to move to Summit, NJ in or around early 2025.)
Travel %: 15 %
Pay: $102,000 to $163,300
What you will do
The Associate Manager, Regulatory Affairs is responsible for regulatory responsibility for products across needs-states, which may include Digestive Health and key brands such as IMODIUM, PEPCID and LACTAID under a wide range of Regulatory classifications (NDA/ANDA, OTC Monograph Drug Products, and Cosmetics). This position resides in Regulatory Affairs within the R&D organization.
Key Responsibilities

• Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classifications.
• Labeling, digital, promotional review and approval, as well as other project execution and post-market related activities.
• Prepare routine submissions to FDA, which may include preparing meeting requests and meeting background packages to FDA.
• Assists in the development of best practices for Regulatory Affairs processes.
• Ensures compliance within the department by ensuring global, regional, and local processes, policies, SOPs and working instructions are adhered to.
• Use knowledge of regulatory landscape, competitive benchmarking, external factors to help shape and inform regulatory strategy.
• Demonstrate successful collaboration and partnership across teams and functions within the organization.
• Monitor competitive landscape and regulatory environment for new industry standards, FDA guidance's, regulations, and draft legislation for impact to the business. May provide support to industry association(s) to provide comments to draft guidance and to help shape regulatory policy.
• Kenvue operates in a highly regulated businesses environment. The Associate Manager, Regulatory Affairs will champion behaviors that embody Our Core Values.

Required Qualifications

• Bachelor's Degree in a science-related discipline is required.
• A minimum of 6 - 8 years experience in Regulatory Affairs is required.
• Working knowledge of regulatory requirements for various regulatory classifications (i.e., NDA/ANDA, OTC monograph drugs is required.
• Excellent communication, collaboration, and leadership skills are required.
• Knowledgeable of the competitive landscape is required.
• Technical/science-based background is required.
• This position 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

• Advanced degree (Masters, PhD, PharmD, etc.) is preferred.
• Knowledge of INDs, NDAs, ANDAs and OTC monograph products and a basic understanding of the Rx-to-OTC switch process are desirable.
• Regulatory Affairs Certification (RAC) desirable.

What's in it for you
• Annual base salary for new hires in this position ranges from $102,000 to $163,300. This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.
• Competitive Total Rewards Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Employee Resource Groups
• This list could vary based on location/region
*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.