Senior Director, Regulatory Affairs

Kenvue•Summit, NJ

1d•$242,250 - $342,000•Hybrid

About The Position

Kenvue is currently recruiting for a: Senior Director, 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. Role reports to: Vice President Regulatory Affairs NA Location: North America, United States, New Jersey, Summit Work Location: Hybrid What you will do The Senior Director, Regulatory Affairs, is a seasoned regulatory professional with in-depth knowledge of FDA regulatory requirements and guidelines. Responsible for developing and executing regulatory strategies and providing guidance to product development and commercial teams in support of Kenvue’s Self-care product Portfolio. The ideal individual must have proven ability to thrive in a collaborative cross-functional environment, along with strong analytical skills, attention to detail, effective problem-solving abilities, negotiation and strong communication skills. and adaptability is required for this position What you will do

Requirements

Minimum of 10 years of experience in Regulatory Affairs.

Nice To Haves

A minimum of a Bachelor’s degree is required, preferably in a science-related or legal field.
Advance degree preferred but not required.
Experience with INDs, NDAs, ANDA, RX-to OTC Switch 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 distill complex scenarios into simplified guidance for internal teams.

Responsibilities

Provide strategic guidance to the organization in support of creative regulatory strategies for the US and Global Allergy portfolio.
Liase with the FDA and serve as RA lead for Health Authority meetings for innovation products and marketed products.
In-dept knowledge and experience with RX-to-OTC Switch
The ability to influence effectively in a matrixed environment
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.
Interface with senior leaders in business to develop, implement, and maintain policies and standards
Oversee and provide guidance to the regulatory team approving budgets, strategies, product claims in accordance with internal procedures and external guidelines
Oversee the technical team responsible for creation and maintenance of Self-care product innovation labeling.
Develop and maintain procedures for key regulatory processes.
Set objectives for RA SC team members in alignment with organizational goals and objectives.
Perform other duties as assigned