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Full-time
bachelor degree
Posted 16d ago
Apply by Aug 31
~40 hrs/week
Responsibilities
Leads the Northern Europe Regulatory Affairs team to ensure successful product registrations and compliance with local regulations. Provides strategic vision and manages regulatory pathways to align with business objectives and market access.
Requirements
Requires a Bachelor's degree or higher and over 10 years of related regulatory experience across medicinal products, cosmetics, and medical devices. Must possess strong leadership skills and a deep understanding of regulatory frameworks in relevant markets.
Full job description
Kenvue is currently recruiting for a:
Northern Europe Regulatory Affairs Director
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:
Senior Director interim leader for Regulatory, EMEA
Location:
Europe/Middle East/Africa, United Kingdom, Reading, Berkshire
Work Location:
Hybrid
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
Essential duties and responsibilities
The Roles & Responsibilities include:
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 applicable local Health Authority requirements.
Monitors implementation of regulatory strategies relative to product and clinical safety issues identified
Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development, regulatory approval and/or market access of new products
Provides regulatory guidance on strategy for proposed product claims/labeling and provided clinical and non clinical data, to ensure compliance with the 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 local 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 local legislative/regulatory requirements.
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
Specific requirements
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
Excellent knowledge of required regulatory frameworks including medicines, medical devices and dietary supplement regulation as a minimum
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.
High degree of organizational and analytical skills, able to demonstrate sound judgment & develop creative solutions
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.
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.
Kenvue is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage and propelled forward by science, our iconic brands — including Aveeno®, BAND-AID® Brand Adhesive Bandages, Johnson’s®, Listerine®, Neutrogena®, Tylenol® and Zyrtec® — are recommended by health care professionals and can be trusted by consumers who use our products to improve their daily lives. Our team members share a digital-first mindset, with an approach to innovation grounded in deep human insights and work every day to earn a place for our products in consumers’ hearts and homes. At Kenvue, we believe everyday care can not only make people well; it can make them whole.
Beware of recruitment scams: https://www.kenvue.com/media/recruitment-scams-alert
Offices: Summit, New Jersey 07901, US
Consumer HealthCPGEssential HealthSkin Health & BeautySelf CareDigitalBrand MarketingSupply ChainRetail HealthConsumer Health Products
How many Science & Research jobs are open in Reading, United Kingdom right now?
There are currently 90 open science & research positions in Reading, United Kingdom listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Reading, United Kingdom?
Companies currently hiring include Oxford Quantum Circuits (OQC), IQVIA, ICON plc, Thales, Intuitive, among others. Browse the listings above to see every active employer.
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