Associate Director, Regulatory Affairs, Self-Care

Description

Kenvue is currently recruiting for a:

Associate Director, Regulatory Affairs, Self-Care

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, is responsible for developing regulatory strategies and providing guidance to product development and commercial teams in support of Kenvue's Self-care products Portfolio.

Key Responsibilities


* Provide strategic guidance to the organization in support of creative regulatory strategies for the US Selfcare portfolio.


* Liase with the FDA and serve as RA lead for Health Authority meetings for innovation products and marketed products.


* Proactively scan and engage in the external environment and provide regulatory intelligence and insights to internal teams to anticipate and prepare for changing regulatory requirements.


* Leverage your knowledge of the consumer healthcare products industry to shape internal product development, claims, and labeling processes such that they are efficient, compliant and fit-for-purpose.


* Oversee and provide guidance to the regulatory team approving promotional materials and product claims in accordance with internal procedures and external guidelines


* Oversee the technical team responsible for creation and maintenance of Self-care product labeling.


* Develop and maintain procedures for key regulatory processes.


* Set objectives for RA team members in alignment with organizational goals and objectives.

What we are looking for

Required Qualifications


* Minimum of 6 years of experience in Regulatory Affairs.

Desired Qualifications


* A minimum of a Bachelor's degree is required, preferably in a science-related or legal field.


* Experience with INDs, NDAs, ANDA and leading health authority meetings.


* Experience working with industry counterparts and trade association committees and task groups is preferred.


* A proactive, big picture strategic thinker who can...