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Description

Kenvue is currently recruiting for:

Regulatory Affairs Manager

This position reports to Director, Regulatory Affairs and is based at 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.)

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: Director, 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 %: 10%

Pay: $111,000 to $192,050

What you will do

The Regulatory Affairs Manager is responsible for regulatory project responsibility for products across needs-states across the Skin Health & Beauty Segment, which may include oversight to key brands such as (NEUTROGENA, AVEENO); covering a wide range of Regulatory classifications (OTC NDA drugs, OTC Monograph drugs, Cosmetics, Medical Devices, and Dietary Supplements). The candidate will be the primary regulatory lead on cross-functional project teams advising and developing US and Global regulatory strategies, identifying creative claims for innovation and marketed products. The candidate will be responsible for delivering and meeting key product launch milestones within a fast paced-environment.This position resides within the R&D organization, Regulatory Affairs function

Key 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.
Review and approval of product labeling, digital, promotional review, as well as other project execution and post-market related activities.
Assemble routine health authority (FDA) submissions, which may include preparing meeting requests and meeting background packages.
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.
Identifies and leads process improvement workstreams.
Monitors external regulatory environment for new industry standards, FDA guidances, regulations, and draft legislation for impact to the business. May work with industry association(s) to provide comments to draft guidance and to help shape regulatory policy.
People leadership to direct report and contractors (as applicable)
Provide guidance regarding regulatory compliance issues
Kenvue operates in a highly-regulated businesses environment. The Manager, Regulatory Affairs will champion behaviors that embody Our Core Values.


Qualifications

What we are looking for

Required Qualifications

Bachelor's Degree is required in a science or science-related field is required.
8-10 Years Work Experience is required.
5 years of direct experience in Regulatory Affairs is required.
Experience and working knowledge of US drug regulations (OTC monographs and NDA/ANDAs), Cosmetics, is required.
Experience in developing and executing Regulatory strategies is required.
Excellent communication, collaboration, and leadership skills are required.
Experience successfully contributing to or leading regulatory launch strategies, submissions and meetings with Health Authorities is required.
Demonstrated abilities to partner with cross-functional teams including Business Development, Marketing, Medical, Clinical and Safety, and Regional Regulatory affairs partners 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, at all company levels, within Kenvue Inc. and externally with regulatory agencies, industry partners, contractors, and service providers is required.
This job will be located in Skillman/Summit, NJ, USA and will be on-site. This position may require travel up to 10% to local sites in the area, as well as other locations based on business needs.


Desired Qualifications

An advanced degree and/or Regulatory Affairs Certification (RAC) is desirable
Class I/II Medical Devices and Dietary Supplements, is desirable.


What's in it for you
Annual base salary for new hires in this position ranges from $111,000 to $192,050. 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...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity