Senior Specialist, Regulatory Affairs

What we do

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.

Who We Are

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 future–and yours. For more information, click here.

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What you will do

Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules for new drug application and investigational new drug applications.

Responsiblity

1.     Be responsible for innovation projects’ notification and registration, closely monitoring registration status, and making sure regulatory milestone on-time delivery.

2.     Actively collaborate with MKT/R&D, providing robust and innovative claims supported with sound science to drive competitive advantage.

3.     Proactively finishing internal compliance tasks to meet internal process and requirements, maintain RA information in internal system.

4.     Implementations by proactively partnering with business stakeholders in aligning, planning and developing regulatory strategies in line with the franchise priorities. effectively manage product registration and notification, claims assessment, AW/label approvals, dossiers preparation and on-time submission, monitoring the progress, status, and timelines.

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