ASSOCIATE MANAGER, REGULATORY AFFAIRS

ASSOCIATE MANAGER, REGULATORY AFFAIRS

私たちがしていること

Kenvueで、日常のケアの並外れた力を実感します。100年以上にわたる伝統を基盤に、科学に根ざした当ホテルは、ニュートロジーナ®、アヴェーノ®、タイレノール®、リステリン®、ジョンソンズ®、バンドエイド®など、すでにお馴染みのアイコニックなブランドを展開しています。科学は私たちの情熱です。ケアは私たちの才能です.

Who We Are

私たちのグローバルチームは~22,000人の優秀な人々で、すべての声が重要で、すべての貢献が評価される職場文化を持っています。 私たちは洞察に情熱を注いでいます。 革新とお客様に最高の製品を提供することに取り組んでいます。専門知識と共感力を持つKenvuerであることは、毎日何百万人もの人々に影響を与える力を持つことを意味します。私たちは人を第一に考え、熱心に気を配り、科学で信頼を勝ち取り、勇気を持って解決します。そして、素晴らしい機会があなたを待っています!私たちと一緒に、私たちの、そしてあなたの未来を形作りましょう。詳細についてはをクリックしてくださいhere.

Role reports to:

Associate Director Regulatory Affairs

Location:

North America, United States, New Jersey, Summit

勤務地:

ハイブリッド

あなたがすること

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.

 

それは何ですか

$127,075.00 - $179,400.00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

Kenvueは機会均等雇用者であることを誇りに思っています。人種、肌の色、宗教、性別、性的指向、性同一性、年齢、出身国、または保護された退役軍人の地位に関係なく、すべての資格のある応募者は、能力に基づいて雇用の検討を受け、障害に基づいて差別されることはありません。