Regulatory Affairs Specialist

2 weeks ago

High Wycombe, Buckinghamshire, United Kingdom Kenvue Full time

At Kenvue, we are seeking a highly skilled Regulatory Affairs Specialist to oversee 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 successful candidate will be responsible for compiling and submitting applications, resolving Health Authority questions, and managing post-approval commitments and submission of variations/renewal applications.

This role reports into the Associate Director Regulatory Affairs and is based at High Wycombe, with a hybrid working arrangement.

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.

The ideal candidate will have a strong understanding of regulatory requirements and guidelines, as well as excellent communication and project management skills.

Key responsibilities include:

  • Assisting in the coordination, compilation, and submission of new drug applications, cosmetics, medical devices, food supplements, or any similar product to the regulatory agencies within the UK, Ireland, and Malta.
  • Collecting and organizing information on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
  • Preparing and submitting regulatory submissions according to applicable regulatory requirements and guidelines.
  • Monitoring the progress of the regulatory authority review process through appropriate communication with the Health Authority.
  • Prioritizing, planning, and monitoring allocated projects against defined timelines.
  • Developing and maintaining a thorough understanding of the regulatory environment and supporting data requirements.
  • Assisting in the maintenance of compliance for all products with local regulations and quality system requirements.
  • Ensuring that all assigned products comply with local regulatory and quality system requirements.
  • Reviews and approves promotional materials for assigned local Kenvue products (if relevant).
  • Initiates, reviews, and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
  • Monitors progress of applications against set timelines, acting where necessary to minimize delays and anticipate difficulties.
  • Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
  • Tracks the status of applications under regulatory review and provides updates to the wider Kenvue teams.
  • Assists in the identification and initiation of local process improvement opportunities and manages changes as required.
  • Assists in the preparation for internal and external audits and inspections in collaboration with others.
  • Assists and ensures compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
  • Assists in trade association, working groups, developing impact assessments influencing regulatory strategies, and leading solutions at a local level (if relevant).
  • Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
  • Participates in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs, and working instructions.

Qualifications

Primary Location: Europe/Middle East/Africa-United Kingdom-England-High Wycombe

Job Function: Regulatory Compliance

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