Associate Director, Regulatory Affairs, CMC

Description

Kenvue is currently recruiting for a:

Associate Director, Regulatory Affairs, CMC

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:
Vice President Regulatory Affairs NA

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

Work Location:
Hybrid

What you will do

The Associate Director, Regulatory Affairs CMC, is responsible for developing regulatory strategies and providing guidance to product development and commercial teams in support of Kenvue's Skin Health and Beauty (SH&B) products Portfolio.

Key Responsibilities


* Prepares CMC regulatory product strategies.

Prepares and manages regulatory submissions, including new applications and amendments, annual reports, supplements and variations and responds to regulatory information.


* Analyzes and interprets information that impacts regulatory decisions.

Seeks expert advice and technical support as required for strategies and submissions.


* Ensure the timely submission of INDs, NDAs, amendments, and supplements for assigned products/projects.


* Develops strategies for CMC agency meetings.

Manages preparation for agency meetings, and content of pre-meeting submissions.

Serves as the point of contact for the regulatory agency meetings.


* Manage products and change control with an understanding of regulations and company policies and procedures.

Analyzes and approves manufacturing change requests.


* Represents CMC regulatory affairs on cross-functional teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.


* Stays abreast of regulatory procedures and changes in regulatory climate.

Analyzes legislation, regulation and guidance, provides analysis to the organization.


* Develops, implements, and documents policies and procedures within the regulatory affairs department.

Leads initiatives internal to RA CMC.


* Serve as the Regulatory Affairs representative on project teams; manage the progress of projects by providing direction, solutions, and feedback to the ...