EMEA Senior Regulatory Affairs Specialist - Self Care

The EMEA 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 franchise (Digestive, Cough). This position reports into the Associate Director Regulatory Affairs and is based at High Wycombe (hybrid).,

• Works with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results and develops global/regional dossiers to support local review processes
• Organizes materials from preclinical and clinical studies for review and assists in the review process
• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines
• Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings
• Tracks the status of applications under regulatory review and provides updates to the regulatory team
• Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at regional level
• Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders
• Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments
• Participate in the development and implementation of, and maintain 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 locally
• Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives
• Support internal and external audits and inspections in collaboration with quality function
• Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.) and maintains information resources
• Supports in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant)
• Provides technical and leadership development as appropriate
• Monitors progress of applications of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties
• Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility
• Works with strategic direction to perform with independent judgment and execution which directly impacts the operational results of the business unit
  
  Relevant Bachelor's Degree or higher
• At least 5 years of relevant working experience
• Expertise across a broad spectrum of the EMEA Regulatory classifications including Drugs, Dietary Supplement 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
Desired Qualifications
• Knowledge of consumer healthcare environment and product development (especially Digestive, Cough)
• Understanding of processes and departments within a healthcare company
• Effective time and organisation management
  
  J&J Family of Companies EMEA Senior Regulatory Affairs Specialist - Self Care 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.