ASSOCIATE MANAGER, REGULATORY AFFAIRS

我們做什麼

在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

Role reports to：

位置：

工作地點：

你會做什麼

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.

對您有什麼好處

這考慮了許多因素，包括工作地點、候選人的技能、經驗、教育水準和其他與工作相關的因素

Kenvue 很自豪能成為一個機會均等的雇主。所有合格的申請人都將根據業績獲得就業考慮，不分種族、膚色、宗教、性別、性取向、性別認同、年齡、國籍或受保護的退伍軍人身份，並且不會因殘疾而受到歧視。