ASSOCIATE MANAGER, REGULATORY AFFAIRS

ASSOCIATE MANAGER, REGULATORY AFFAIRS

Lo que hacemos

En Kenvue, nos damos cuenta del extraordinario poder del cuidado diario. Sobre la base de más de un siglo de herencia y arraigados en la ciencia, somos el hogar de marcas icónicas, incluidas NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® y BAND-AID® que ya conoces y amas. La ciencia es nuestra pasión; El cuidado es nuestro talento.

Quiénes somos

Nuestro equipo global está formado por ~ 22.000 personas brillantes con una cultura laboral en la que cada voz importa y cada contribución es apreciada. Nos apasionan las ideas, innovación y comprometidos con la entrega de los mejores productos a nuestros clientes. Con experiencia y empatía, ser un Kenvuer significa tener el poder de impactar a millones de personas todos los días. Ponemos a las personas en primer lugar, nos preocupamos ferozmente, nos ganamos la confianza de la ciencia y resolvemos con coraje, ¡y tenemos oportunidades brillantes esperándote! Únase a nosotros para dar forma a nuestro futuro y al suyo. Para obtener más información, haga clic en aquí.

Role reports to:

Associate Director Regulatory Affairs

Location:

North America, United States, New Jersey, Summit

Lugar de trabajo:

Híbrido

What will you

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

$127,075.00 - $179,400.00

Esto tiene en cuenta una serie de factores que incluyen la ubicación del trabajo, las habilidades del candidato, la experiencia, el nivel de educación y otros factores relacionados con el trabajo.

Kenvue se enorgullece de ser un empleador que ofrece igualdad de oportunidades. Todos los solicitantes calificados recibirán consideración para el empleo basada en el mérito sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, edad, origen nacional o estado de veterano protegido y no serán discriminados por motivos de discapacidad.