Senior Associate Regulatory Specialist

Description

Kenvue is currently recruiting for a:

Senior Associate Regulatory 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:
Director RA Dietary Supplements

Location:
North America, United States, New Jersey, Summit

Work Location:
Hybrid

What you will do

The Senior Associate Regulatory Specialist is responsible for ensuring compliance with regulatory agency regulations, preparing responses to regulatory agencies' questions, gathering necessary information for submissions, and providing solutions to problems of moderate scope and complexity:

Key Responsibilities


* Lead regulatory submissions for new product approvals and post-approval changes


* Develop and maintain regulatory strategies to ensure compliance with global regulations


* Provide regulatory guidance to cross-functional teams on product development and lifecycle management


* Conduct regulatory intelligence to stay abreast of changes in regulations and guidelines


* Collaborate with regulatory agencies to address inquiries and resolve issues


* Lead and manage regulatory activities for a diverse portfolio of products


* Collaborate with cross-functional teams to develop and implement regulatory strategies


* Review and approve promotional materials to ensure compliance with regulatory guidelines


* Provide guidance and support on regulatory processes such as Drug Listing and Periodic Safety Reporting


* Develop and maintain reporting schedules for regulatory submissions


* Present status updates on regulatory activities to key stakeholders


* Participate in joint company/trade association initiatives and regulatory agency meetings


* Drive continuous improvement in Regulatory Affairs processes and best practices


* Ensure quality and compliance in all regulatory actions

What we are looking for
Required Qualifications


* Bachelor's degree in a scientific discipline or related field


* 4-6 years of experience in regulatory affairs within the pharmaceutical industry


* Strong knowledge of global regulatory requirements and guidelines
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