UK/IE Skin Health Regulatory Affairs Manager

UK/IE Skin Health Regulatory Affairs Manager

O que fazemos

At Kenvue, percebemos o extraordinário poder do cuidado diário. Construída com base em mais de um século de herança e enraizada na ciência, somos a casa de marcas icônicas - incluindo NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® que você já conhece e ama. A ciência é a nossa paixão; O cuidado é o nosso talento.

Quem somos

Nossa equipe global é de ~ 22.000 pessoas brilhantes com uma cultura no local de trabalho onde cada voz é importante e cada contribuição é apreciada. Somos apaixonados por insights, inovação e comprometidos em entregar os melhores produtos aos nossos clientes. Com experiência e empatia, ser um Kenvuer significa ter o poder de impactar milhões de pessoas todos os dias. Colocamos as pessoas em primeiro lugar, nos importamos ferozmente, ganhamos confiança com a ciência e resolvemos com coragem - e temos oportunidades brilhantes esperando por você! Junte-se a nós para moldar nosso futuro - e o seu. Para obter mais informações, clique em aqui.

Role reporta para:

Sr Dr Northern Europe and Head of S&EH

Localização:

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

Local de trabalho:

Híbrido

O que você fará

Job title: UK/IE Skin Health Manager Regulatory Affairs

Reporting to: Director Regulatory Affairs

Functional group: EMEA Regulatory Affairs (R&D)

Location: Reading, United Kingdom

Job Description

The Manager Regulatory Affairs is a country expert with an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements and strategies for regulatory submissions, approval pathways and compliance activities and the potential impact of these on business objectives.

· Ensures the success of new product registrations, line extensions and new indications and claims in alignment with the business plan,

· Create an environment of operational excellence through regulatory expertise by managing and developing direct reports and collaborating with cross-functional teams to successfully achieve affiliate regulatory objectives

· Manages the coordination, compilation, submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies within their geographical and/or brand area of responsibility

· Maintains compliance for all products with local regulations and quality system requirements

· 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, functional and business Leadership teams

The role requires close cooperation with Commercial/Marketing teams within a cluster.

The Roles & Responsibilities include:

Regulatory Strategy

· Provides regulatory input and technical guidance on local 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.

· Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non clinical data are consistent with the local regulatory requirements and support the proposed product claims.

· Prepares and submits regulatory submissions according to applicable local regulatory requirements and guidelines.

· Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.

· Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional level.

Regulatory Compliance

· Maintains awareness of current regulations and anticipates implications and opportunities as a result of changes to the relevant regulatory environments. Communicates changes to appropriate management and cross functional experts as appropriate and implements locally

· Ensures that all products comply with local regulatory and quality system requirements.

· Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions

· Reviews and approves promotional materials for all local Kenvue products and assists in claim support along with the Cluster.

· Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.

· Ensures 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

Specific requirements

· Relevant Bachelor's Degree or higher

· 8+yrs related regulatory experience

· Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices

· Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.

· Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance

· Leadership and coaching skills with proven experience of people development

· Proficiency in English

• Be member of Pharmacist association

• Be designated QP by the Health Authorities

• Knowledge of GMP and European legislation (Eudralex, Directive, ISO) for pharmaceutical products

• Knowledge of production, Quality Assurance, Quality Control, validation.

• At least 2 years of experience as QP deputy

Other features of the job

· Qualified Person

· Responsible Person

· Management & oversight of GMP Inspections and/or

· Compilation & submission of Pricing Applications &/or product reimbursement requests to the relevant national Regulatory authorities

· Be the representative of the company for the Health Authorities, as responsible Qualified Person.

· Approve and be responsible for all technical documentation related with registration and Marketing Company authorization.

· Ensure compliance with the authorized specifications of each product.

· Ensure that GMP’s are applied, even if these operations are outsourced to an external manufacturer.

· Approve all Business Quality procedures of the marketing Company.

· Release into the market each batch, once conformity with approved specifications is verified. Formalize this release through appropriate documents, which must be updated and available for auditors. OTC Batch release approvals and batch assignments approvals prepared and issued by Local Business Quality.

· Support the Health Authorities during inspections.

· Manage recall of products from the market, if needed, and communicate this decision to the Health Authorities.

· Verify the correct distribution of products.

Essential knowledge and skills:

· Excellent knowledge of required regulatory frameworks including medicines regulation and/or cosmetic regulation as a minimum within their geographic area of responsibility

· Strong personal and people leadership, able to coach and develop emerging talent

· Broad knowledge of consumer healthcare environment and product development

· 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.

· Strong organizational and time management skills with an ability to work under pressure.

· Demonstrable commercial focus and business acumen which will enable him/her to thrive in a fast-paced, dynamic, Results-driven environment.

· 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 Regulatory Affairs function on cross-functional teams and governance forums.

· Able to work effectively in a multi-cultural, highly matrixed organization

· Experience in cultivating and leveraging strategic networks and partnerships

· Proficiency in English

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