Kenvue

Manufactures and markets consumer health products.

CE Regulatory Affairs Director

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeNo salary listed

About the Job

Requirements

A relevant bachelor's degree or higher is required.
At least 10 years of related regulatory experience is required.
Expertise across a broad spectrum of regulatory classifications, including medicinal products, cosmetics, commodities, and/or medical devices, is required.
A solid understanding of regulatory, medical, safety, and quality requirements in relevant markets is required.
Proficiency in English is required.

Responsibilities

Lead the Cluster Regulatory Affairs team, ensuring successful local deployment of new product registrations, line extensions, new indications, and claims in alignment with the business plan while maintaining compliance for all products with local regulations and quality system requirements.
Provide strategic vision and create an environment of operational excellence through regulatory expertise by managing and developing direct reports and collaborating with cross-functional teams to achieve local and regional regulatory objectives.
Manage the Cluster Regulatory Affairs team and oversee associated regulatory spend.
Assess links between global, societal, public health, and economic trends; stakeholder concerns and regulatory issues and requirements; and implications for regulatory strategy.
Develop and implement regulatory plans and strategies in alignment with agreed business plans and in compliance with applicable global and/or regional regulatory requirements.
Analyze the adequacy of proposed regulatory pathways and strategy for initial product designs and recommend changes or refinements based on initial regulatory outcomes.
Cultivate external relationships, representing the company with relevant regulatory agencies and industry and professional associations as required.
Represent the Regulatory Affairs function as appropriate in Cluster and EMEA Regulatory Affairs Leadership teams.
Provide strategic input and technical guidance on local and regional regulatory requirements to product development teams.
Assess the acceptability of quality, preclinical, and clinical documentation for submission filing to meet applicable requirements.
Maintain awareness of current regulations and anticipate implications and opportunities arising from changes to the relevant regulatory environment; communicate changes to appropriate management, advise internal stakeholders and cross-functional experts on courses of action, and oversee local implementation.
Negotiate with regulatory authorities on complex issues throughout the product lifecycle.
Identify the need for and manage the development and execution of new regulatory procedures and standard operating procedures.
Oversee compliance of all product artwork and promotional materials for local company products.
Ensure enterprise Regulatory systems are accurate and fully maintained.
Ensure compliance issues are reviewed and escalated and that relevant corrective and preventive actions are implemented locally.
Identify local process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives.
Manage and support internal and external audits and inspections in collaboration with the quality function.
Remain up to date on scientific and clinical advances that affect healthcare product development and assess their relationship to regulation and regulatory issues.
Drive new approaches to improve the development, review, and oversight of regulatory frameworks for healthcare products in the area of geographic responsibility.
Engage with external stakeholder groups to help shape science-based regulatory decision-making as required.

Kenvue/Kimberly Clark is currently recruiting for:

CE Regulatory Affairs Director (m/f/d)

This position reports into Serenella Cascio and is based at Neuss.

What we do

At Kenvue/Kimberly Clark, 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: Serenella Cascio

Location: Neuss

What you will do

The Director of Regulatory Affairs has an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements and strategies for regulatory submissions and approval pathways and the potential impact of these on business objectives.

Leads the Cluster Regulatory Affairs team, ensuring successful local deployment of new product registrations, line extensions, new indications and claims in alignment with the business plan, while maintaining compliance for all products with local regulations and quality system requirements.
Provides strategic vision & creates an environment of operational excellence through regulatory expertise by managing and developing direct reports and collaborating with cross-functional teams to successfully achieve local/regional regulatory objectives.
Management of the Cluster Regulatory Affairs team & oversight of associated regulatory spend
Assesses links between global, societal, public health and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy.
Develops and implements regulatory plans and strategies in alignment with agreed business plans and in compliance with applicable global and/or regional regulatory requirements.
Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes.
Facilitates and cultivates external relationships, representing Kenvue with the relevant regulatory agencies and industry & professional associations as required
Represents the Regulatory Affairs function as appropriate in Cluster and EMEA Regulatory Affairs Leadership teams.

Regulatory Strategy

Provides strategic input and technical guidance on local/regional regulatory requirements to product development teams.
Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicabl

Regulatory Compliance

Maintains awareness of current regulations and anticipates implications and opportunities as a result of changes to the relevant regulatory environment. Communicates changes to appropriate management, advises internal stakeholders on a course of action and cross functional experts as appropriate, and oversees local implementation
Negotiates with regulatory authorities on complex issues throughout the product lifecycle.
Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures (SOPs).

Oversees compliance of all product artworks and promotional materials for all local Kenvue products
Accountable for ensuring that the enterprise Regulatory systems are accurate and fully maintained
Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally
Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives
Manages and supports internal and external audits and inspections in collaboration with quality function

Regulatory Advocacy

Remains up-to-date on scientific and clinical advances that impact healthcare product development and assesses the relationship to regulation and regulatory issues.
Drive new approaches to improve the development, review and oversight of regulatory frameworks for healthcare products in their area of geographic responsibility.
Engages with external stakeholder groups to help shape science-based regulatory decision making as required

What we are looking for

Relevant Bachelor's Degree or higher
10+yrs related regulatory experience
Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices
Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
Proficiency in English

About the Company

Kenvue

Manufactures and markets consumer health products.

Kenvue is the world's largest pure-play consumer health company, focusing on the development, manufacturing, and sale of over-the-counter medicines, personal care, skincare, and wound care across three segments: Self Care, Skin Health & Beauty, and Essential Health. Its products use established, science-backed formulas to address everyday health needs, from pain relief and allergy care to hygiene and skincare, sold through retailers and direct-to-consumer channels in more than 165 countries. The company differentiates itself with a long-running brand portfolio, a broad global distribution network, and a data-driven marketing approach that supports strong brand leadership. Its goal is to maintain market leadership in consumer health, grow its brands and channels (including direct-to-consumer), and explore strategic options while expanding globally.

Company size: 10,001+
Company stage: IPO
Headquarters: Montgomery Township, New Jersey
Founded: 2023

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