Regulatory Affairs Director

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Northern Europe Regulatory Affairs Director 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. care is our talent. 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. We put people first, care fiercely, earn trust with science and solve with courage and have brilliant opportunities waiting for you! Senior Director interim leader for Regulatory, EMEA Hybrid 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 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 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 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 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. able to build effective personal networks internally and externally. 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. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
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Location:
Bracknell
Job Type:
FullTime

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