Senior Associate Regulatory Specialist

Description

Kenvue is currently recruiting for a:

Senior Associate Regulatory Specialist

What we do

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.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.

We are 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 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 RA Dietary Supplements

Location:
North America, United States, New Jersey, Summit

Work Location:
Hybrid

What you will do

The Senior Associate, Regulatory Affairs is responsible for developing regulatory strategy and providing guidance to product development and commercial teams in support of Kenvue's Dietary Supplement Portfolio.

Key Responsibilities


* Monitor and advise on the regulatory landscape for the Kenvue Dietary Supplement portfolio, and manage regulatory activities for marketed products as well as support development of regulatory strategies for new product development (NPD) activities.


* Provide regulatory advice and recommendations to cross-functional product teams in support of new innovations as well as existing products.


* Have responsibility for review and approval of labeling and promotional material and associated product claims.


* Be responsible for representing Regulatory on project teams including teams developing Supplement Information Sheets (SIS).


* Be responsible for submissions to FDA, preparing meeting requests and meeting background packages to FDA as required.


* Prepare and maintain SOPs (Standard Operating Procedures) in support of key regulatory processes.


* Assess changes to relevant regulations and guidance documents to determine relevance to the business.


* Participate in Industry Association Working Groups on behalf of Kenvue

What we are looking for

Required Qualifications


* A minimum of a Bachelor's Degree required.

An advanced degree (Masters, PhD, PharmD, etc.) is preferred.


* A minimum of 3-5 years direct experience in Regulatory Affairs is required.

Desired Qualifications


* Strong understanding and working knowledge of DSHEA ( Dietary Supplement Health and Education Act .) and related guidance.

Knowledge of global requirements related to Dietary Supplements is a strong asset but not required.


* Experience working with cross-funct...