Regulatory Affairs Specialist

2 weeks ago


High Wycombe, Buckinghamshire, United Kingdom Kenvue Full time

Role Summary


The Senior Regulatory Affairs Specialist Self Care will be responsible for developing global and regional regulatory strategies, coordinating regulatory actions, and developing global/regional dossiers to support local review processes.


Key Responsibilities



  • Work with local and regional regulatory colleagues to develop global and/or regional regulatory strategies
  • Coordinate regulatory actions and results, and develop global/regional dossiers to support local review processes
  • Organize materials from preclinical and clinical studies for review and assist in the review process
  • Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines
  • Assist in the scheduling of meetings with internal stakeholders and regulators and develop and organize materials for these meetings
  • Track the status of applications under regulatory review and provide updates to the regulatory team
  • Familiarize and understand the current regulatory legislation to keep the legislative knowledge up to date at regional level
  • Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders
  • Ensure awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments

Requirements


The successful candidate will have a strong understanding of regulatory affairs, excellent communication and project management skills, and be able to work effectively in a team environment.


About Kenvue


Kenvue is a global house of iconic brands, dedicated to delivering the best products to our customers. We put people first, care fiercely, earn trust with science, and solve with courage.


How to Apply


Please submit your application, including your CV and a cover letter, to [insert contact information].



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