ASSOCIATE MANAGER, REGULATORY AFFAIRS

Associate Manager, Regulatory Affairs

Kenvue is currently recruiting for a :

Associate Manager, Regulatory Affairs

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 ~ 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 futureand yours.

Role reports to : Associate Director Regulatory Affairs

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

Work Location : Hybrid

What you will do :

Provides regulatory expertise and support for the registration of Kenvue's US products in the Caribbean Region. Partners with Kenvue's representative agents who liaise with the Ministries of Health in the Caribbean region. Provides data and documentation required for the registration of Kenvue's US products. Serves as Kenvue's Representative Agent with the Health Department in Puerto Rico and registers Kenvue's US OTC drug products in Puerto Rico. Provides direction and regulatory guidance to New Product Development (NPD) teams for the registration of Kenvue's products in the Caribbean region. Collaborates with Kenvue colleagues in Sales, Marketing, Master Data, Regulatory Affairs, Quality, and Legal, ensuring compliance with associated regulatory requirements and internal standards applicable to the distribution of Kenvue's US products in the Caribbean region. Under limited supervision and in accordance with all applicable federal, state, and local laws / regulations, the Companies' policies, procedures and guidelines, this position :

Serves as the primary regulatory contact for the Kenvue Company in the Caribbean region. Works

with a portfolio of Kenvue products, including but not limited to the following brands : Aveeno,

Band-Aid, Benadryl, Bengay, Clean & Clear, Desitin, Imodium, Johnson's, Listerine,

Lubriderm, Motrin, Neosporin, Neutrogena, Pepcid, Rogaine, Tylenol, Visine, and

Zyrtec.

Works with North America and Global Regulatory Affairs and contracted agents representing partners

managing products registrations, renewals and approvals for the Consumer and OTC drug products in

Puerto Rico and the other markets comprising the Caribbean region.

Ensures compliance with current regulatory standards for the release and export of the company's

products in the Caribbean region.

Ensures that the company's products sold in each market in the Caribbean region comply with the

regulations of the Health Authorities.

Notifies authorities of any product variations or updates affecting products sold.

Archives all regulatory documentation, including submissions and approvals, in accordance with

internal standards and policies.

Manages dossier preparation, using critical and confidential GMP documentation from Kenvue

electronic documentation systems, such as RegPoint, CAPRI, CEDMS, and Symphony EtQ.

Prepares and approves Consumer Regulatory Clearance for Caribbean Region.

Submits on monthly basis registration report for Caribbean Region.

Reviews all dossiers to ensure compliance with the applicable regulations for the relevant Caribbean

market(s).

Prepares and submits documentation for the registration of Kenvue products in Puerto Rico.

Interacts with Puerto Rican Department of Health personnel to resolve registration matters.

Approves change controls and provides deliverables for products distributed in the Caribbean.

Maintains current knowledge base of existing and emerging regulations, standards, or guidance

documents impacting on the registration of products in the Caribbean.

Works with product changes and new product introductions, providing RA clearance and / or approval

to release products in the Caribbean markets.

Provides registration strategies for products distributed in the Caribbean.

Supervises, trains and provides guidance to contract staff who prepare dossiers for the Caribbean

markets.

Attends relevant meetings as needed

Requirements :

Education : Bachelor's Degree in science is required.

Experience : 6-8 years of experience in Regulatory Affairs (can be a combination of QA / RA experience) is

required. Experience in the preparation of dossiers for product registrations (OUS) preferred. Experience

in international Regulatory Affairs preferred.

Knowledge, Skills and Abilities : Excellent oral and written communication skills are required. Fluency in

English required. Fluency in Spanish preferred.

What's in it for you :

Annual base salary for new hires in this position ranges :

$127,075.00 - $179,400.00

This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.

Competitive Benefit Package

Paid Company Holidays, Paid Vacation, Volunteer Time & More!

Learning & Development Opportunities

Kenvuer Impact Networks

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 merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.