Senior Regulatory Affairs Specialist - Cosmetics

Job Description

Kenvue is currently recruiting for a-

Senior Regulatory Affairs Specialist - Cosmetics

This position is based at High Wycombe (hybrid)

Who We Are

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. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of 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.

What You Will Do

In this role, you will be responsible for the management of a number of products within a therapy area for OTC in the UK, Ireland and Malta. You will look into the development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.

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

Key responsibilities include-

Regulatory Strategy

• Works independently to provide 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, where relevant.
• 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 classification and claims.
• Prepares and submits regulatory submissions according to applicable 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 assigned local Kenvue products and assists in claim support.
• 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.
• Supports internal and external audits and inspections in collaboration with quality function.
  
  

What We Are Looking For

You will have 6 + yrs experience within the Regulatory Affairs environment ideally supporting Cosmetics and be able to demonstrate the following-

• Relevant Bachelor's Degree or higher.
• The successful individual will have excellent business partnering, analytical and communication skills.
• 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.
• Proficiency in English.
  
  

Nice to haves-

• Be designated QP by the Health Authorities.
• Knowledge of production, Quality Assurance, Quality Control, validation.
  
  

What’s In It For You

• Competitive Benefit Package
• Paid Company Holidays, Volunteer Time, option to buy and sell holiday
• Learning & Development Opportunities
• Employee Resource Groups
  
  

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

Europe/Middle East/Africa-United Kingdom-England-High Wycombe

Job Function

Regulatory Affairs