Northern Europe Regulatory Affairs Director

Northern Europe Regulatory Affairs Director

Ce que nous faisons

Chez Kenvue, nous réalisons le pouvoir extraordinaire des soins quotidiens. S'appuyant sur plus d'un siècle d'héritage et enraciné dans la science, nous sommes la maison de marques emblématiques - dont NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® et BAND-AID® que vous connaissez et aimez déjà. La science est notre passion ; Le soin est notre talent.

Qui nous sommes

Notre équipe mondiale est composée de ~ 22 000 personnes brillantes avec une culture d'entreprise où chaque voix compte et chaque contribution est appréciée. Nous sommes passionnés par les idées, l'innovation et l'engagement à fournir les meilleurs produits à nos clients. Avec de l'expertise et de l'empathie, être un Kenvuer signifie avoir le pouvoir d'avoir un impact sur des millions de personnes chaque jour. Nous donnons la priorité aux personnes, nous nous soucions farouchement, nous gagnons la confiance grâce à la science et nous résolvons les problèmes avec courage - et nous vous offrons de brillantes opportunités ! Joignez-vous à nous pour façonner notre avenir et le vôtre. Pour plus d'informations, cliquez sur ici.

Role relève à :

Senior Director interim leader for Regulatory, EMEA

Lieu :

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

Lieu de travail :

Hybride

Ce que tu vas faire

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.

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