Senior Regulatory Affairs Specialist

4 weeks ago

High Wycombe, Buckinghamshire, United Kingdom Kenvue Full time

At Kenvue, we are currently seeking a Senior Regulatory Affairs Specialist to join our team. This role will be responsible for a range of regulatory activities for our assigned medicines, medical devices, cosmetics, and/or food supplement consumer products within the UK, Ireland, and Malta.

The Senior Regulatory Affairs Specialist will be responsible for compilation and submission of applications, resolution of Health Authority questions, post-approval commitments, and submission of variations/renewal applications. This position reports into the Senior Manager/Manager Regulatory Affairs and is based at High Wycombe (hybrid).

We are a global team of 22,000 diverse and brilliant people, passionate about insights, innovation, and committed to delivering the best products to our customers. We put people first, care fiercely, earn trust with science, and solve with courage.

The ideal candidate will have expertise in regulatory affairs and be able to partner with the business to deliver regulatory outcomes. The successful candidate will also be able to coordinate, compile, and submit new drug applications, cosmetics, medical devices, food supplements, or any similar product to the regulatory agencies within the UK, Ireland, and Malta.

The key responsibilities of this role include:

  • Partner with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
  • Coordinate, compile & submit new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies within UK, Ireland, and Malta within area of responsibility.
  • Prepare and submit regulatory applications according to applicable regulatory requirements and guidelines.
  • Initiate, review, and approve new or revised product artworks in collaboration with Cluster Artwork Coordinator.
  • Advise on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
  • Prioritize, plan and monitors allocated projects against defined timelines.
  • Monitor the progress of the regulatory authority assessment through appropriate communication with the Health Authority.
  • Develop and maintain a thorough understanding of the regulatory environment and supporting data requirements.
  • Participate in trade association working groups, and support the development of impact assessments, influencing strategies, and leading solutions at a local level (if relevant).
  • Ensure all assigned products comply with local regulatory and quality system requirements.
  • Monitors progress of applications against set timelines, acting where necessary to minimize delays and anticipate potential risks.
  • Review and approve promotional materials for assigned local Kenvue products (if relevant).
  • Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
  • Ensure that the enterprise Regulatory systems are accurate and fully maintained.
  • Track the status of applications under regulatory review and provides updates to the wider Kenvue teams.
  • Support the identification & initiation of local process improvement opportunities and manage changes as required.
  • Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
  • Monitor the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.) and maintain information resources.
  • Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
  • Participates in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs and working instructions.
  • Identify and/or implement local/regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives.
  • Support internal and external audits and inspections in collaboration with relevant function.
  • Provides technical and leadership development as appropriate.

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