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).,

• 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
  
  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
  
  J&J Family of Companies EMEA Senior Regulatory Affairs Specialist - Food Supplements in England, United Kingdom, 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) .
  
  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.