ASSOCIATE MANAGER, REGULATORY AFFAIRS

reputed company is currently recruiting for a: ASSOCIATE MANAGER, REGULATORY AFFAIRS reputed company do At reputed company, 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 reputed company 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 reputed company, 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 reputed company opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here. 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 reputed company’s US products in the Caribbean Region. Partners with reputed company’s representative agents who liaise with the Ministries of Health in the Caribbean region. Provides data and documentation required for the registration of reputed company’s US products. Serves as reputed company’s Representative Agent with the Health Department in Puerto Rico and registers reputed company’s US OTC drug products in Puerto Rico. Provides direction and regulatory guidance to New Product Development (NPD) teams for the registration of reputed company’s products in the Caribbean region. Collaborates with reputed company 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 reputed company’s US products in the Caribbean region. Under limited supervision and in accordance with reputed company applicable federal, state, and local laws/regulations, the Companies’ policies, procedures and guidelines, this position:

• Serves as the primary regulatory contact for the reputed company Company in the Caribbean region. Works

with a portfolio of reputed company 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 reputed company 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 reputed company with the

regulations of the Health Authorities.

• Notifies authorities of any product variations or updates affecting products sold.
• Archives reputed company regulatory documentation, including submissions and approvals, in accordance with

internal standards and policies.

• Manages dossier preparation, using critical and confidential GMP documentation from reputed company

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 reputed company dossiers to ensure compliance with the applicable regulations for the relevant Caribbean

market(s).

• Prepares and submits documentation for the registration of reputed company 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 reputed company knowledge reputed company 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. reputed company in English required. reputed company in Spanish preferred. What’s in it for you Annual reputed company 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-reputed company factors.

• Competitive Benefit Package*

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

• Learning & Development Opportunities
• Kenvuer Impact Networks
• This list could vary based reputed company/region
• Note: Total Rewards at reputed company 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.

reputed company is proud to be an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability, please reputed company our Disability Assistance page for information on how to request an accommodation. Apply tot his job Apply To this Job