Senior Regulatory Affairs Specialist

3 weeks ago

High Wycombe, Buckinghamshire, United Kingdom Kenvue Full time
Job Title: Senior Regulatory Affairs Specialist

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Kenvue. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for our consumer products in the UK, Ireland, and Malta.

Key Responsibilities:
  • Partner with the business to deliver regulatory outcomes that enable committed business plans within your area of responsibility.
  • Coordinate, compile, and submit new drug applications, cosmetics, medical devices, food supplements, or any similar product to the regulatory agencies within your 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 the Cluster Artwork Coordinator.
  • Advise on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
  • Prioritize, plan, and monitor 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.
  • Monitor the 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 provide updates to the wider Kenvue teams.
  • Support the identification and 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.
  • Participate 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.
  • Provide technical and leadership development as appropriate.
Requirements:

We are looking for a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs, with a proven track record of delivering regulatory outcomes that enable business plans. The candidate will also have excellent communication and project management skills, with the ability to work effectively in a fast-paced environment.

The successful candidate will be a key member of our Regulatory Affairs department, working closely with the business to deliver regulatory outcomes that enable committed business plans. The candidate will be responsible for ensuring compliance with regulatory requirements for our consumer products in the UK, Ireland, and Malta, and will work closely with the Cluster Artwork Coordinator to initiate, review, and approve new or revised product artworks.

The ideal candidate will have a strong understanding of the regulatory environment and supporting data requirements, and will be able to develop and maintain a thorough understanding of the regulatory environment and supporting data requirements. The candidate will also be able to participate in trade association working groups and support the development of impact assessments, influencing strategies, and leading solutions at a local level (if relevant).

We offer a competitive salary and benefits package, as well as opportunities for professional development and growth. If you are a highly skilled and experienced Senior Regulatory Affairs Specialist looking for a new challenge, we encourage you to apply for this exciting opportunity.

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