Regulatory Affairs Senior Specialist

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.

Role reports to:

Location:

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What you will do

Position Summary：

• 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.

• Provides solutions to a variety of problems of moderate scope and complexity.

• Develop problem-solving strategies which drive efficiency within the project teams, ensure product compliance and deliver high-quality submissions per project timelines for Life Cycle management projects.

• Proactive partner with internal business stakeholders (local, regional, global), franchise teams and Cross-Sector RA partners to develop innovative regulatory strategies ensuring that regulatory requirements are incorporated upfront, and project risks are understood and mitigations in place.

• Develop problem-solving strategies which drive efficiency within the project teams.

• Monitor the regulatory environment locally and globally and provide timely assessments to business leaders of the impact of new/changing regulations on the current and future pipeline. Provide consultation, interpretation and advice to relevant departments to ensure on-time compliance with regulatory.

Major Duties & Responsibilities：

• 60%Project RA for LCM activities

• 20%Regulation interpretation and intelligence

• 10%External engagement (HA and industrial association)

• 10%Other RA activities

Required Qualifications：

• Minimum Bachelor's degree in Chemistry, Pharmaceutical or Food, etc.

• Minimum 2 years’ experience in Regulatory Affairs

Required Knowledge, Skills and Abilities:

• Experience and knowledge of regulatory requirements relevant for the categories relevant for the company.

• Skillful written and fluent spoken in English and Mandarin.

• Competencies: Agile and efficient thinking; Stakeholder management; Risk analysis/management

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