Job Information
J&J Family of Companies EMEA Senior Regulatory Affairs Specialist - Food Supplements in England, United Kingdom
EMEA Senior Regulatory Affairs Specialist - Food Supplements - 2407025943W
Description
Kenvue is currently recruiting for:
EMEA Senior Regulatory Affairs Specialist - Food Supplements
The Senior Regulatory Affairs Specialist is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care segment. This position reports into the Regulatory Affairs Manager and is based in High Wycombe (hybrid).
Who We Are
At Kenvue (file:///C:/Users/mable/AppData/Local/Temp/OneNote/16.0/Exported/{B02D4291-C06C-49F6-90DD-94CE44FB7180}/NT/1/kenvue.com/careers) , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSONS and BAND-AID that you already know and love. Science is our passion; care is our talent. Our global team is made up with 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 futureand yours. For more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX_M) .
What You Will Do
Regulatory Strategy
Works with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating and consolidating data requirements and developing global/regional dossiers to support local /EU Health Authority submission
Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority requirements within the EMEA region
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
Works with strategic direction to perform with independent assessment and execution of strategy that directly impacts the operational results of the business unit
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 as appropriate
Monitors progress of applications of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate questions from the Health Authority. Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions
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
Identifies and/or implements regional 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
Qualifications
Required Qualifications
Relevant Bachelor's Degree or higher
At least 5 years of relevant working experience
Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Food Supplements 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 experience of people development
Proficiency in English
Whats In It For You
Competitive Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
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 identity, 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
Req ID: 2407025943W
J&J Family of Companies
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