Skin Health Regulatory Affairs Director - EMEA

Kenvue is currently recruiting for a Skin Health Regulatory Affairs Director - EMEA.

What we do

At Kenvue, we realise 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.

Role reports to: Sr Dr Northern Europe and Head of S&EH

Location: Europe/Middle East/Africa, United Kingdom, Reading, Berkshire

Work Location: Hybrid

What you will do

• The Director of Regulatory Affairs leads the regulatory affairs deliverables for the Skin Care franchise ensuring the success of new product registrations, line extensions and new indications in alignment with the business plan, while overseeing compliance for all products with relevant regulations and quality system requirements.
• Management of the Skin Care Regulatory Affairs team & monitoring of associated regulatory spend.
• 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.
• Assesses links between global, societal, public health and economic trends; stakeholder concerns and regulatory issues and requirements; and the 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.
• 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 Skin Care and EMEA Regulatory Affairs Leadership teams.
• Provides strategic input and technical guidance on global/regional regulatory requirements to product development teams.
• Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.
• Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions.
• Monitors implementation of regulatory strategies relative to product and clinical safety issues identified.
• Provides regulatory guidance on strategy for proposed product claims/labeling and provided clinical and non-clinical data, to ensure compliance with local regulatory requirements and to optimise the proposed product positioning.
• Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process.
• Prepares cross-functional teams for interactions with regulatory authorities including scientific advice meetings.
• Adapts pre and post market strategy based on consideration of factors such as reimbursement, public health policies, state/provincial/regional restrictions and other legislative/regulatory requirements.
• Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches and advises internal stakeholders on a course of action.
• Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products.
• Negotiates with regulatory authorities on complex issues throughout the product lifecycle.
• Ensures that all applicable Processes, SOPs and working instructions are adhered to.
• Supports internal and external audits and inspections in collaboration with quality function.
• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures (SOPs).
• Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
• Remains up-to-date on scientific and clinical advances that impact healthcare product development and assesses the relationship to regulation and regulatory issues.
• Drives new approaches to improve the development, review and oversight of regulatory frameworks for healthcare products.
• Engages with stakeholder groups to help shape science-based regulatory decision making as required.

Requirements

• Relevant Bachelor's Degree or higher.
• 10+ years 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.
• Excellent personal and people leadership.
• Broad knowledge of consumer healthcare environment and product development.

Core competencies

• Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
• Strong interpersonal skills; able to build effective personal networks internally and externally.
• Highly collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
• In-depth knowledge of the business, organizational goals, Regulatory Affairs function, and cross-functional business partners to make informed business decisions and create and execute business strategies.
• Ability to represent RA function on cross-functional teams and governance forums.
• High degree of organizational and analytical skills, able to demonstrate sound judgment & develop creative solutions.
• Able to work effectively in a multi-cultural, highly matrixed organisation.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.