Regulatory Affairs Specialist

1 month ago


High Wycombe, Buckinghamshire, United Kingdom eTeam Workforce Limited Full time

Job Title: Regulatory Affairs Specialist

Job Summary:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at eTeam Workforce Limited. As a key member of our Regulatory Affairs team, you will be responsible for managing post-approval activities for specified OTC products, supporting the EMEA Regulatory Affairs team, and developing regulatory strategies.

Key Responsibilities:

  • Management of post-approval activities for specified OTC products.
  • Support the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA and coordinate worksharing (WS) procedures for CMC and non-CMC variation, when WS is appropriate.
  • Development of regulatory strategies, preparation of regulatory applications, and support maintenance activities for MRP/DCP products.
  • Support the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
  • Support the team with regional regulatory strategies in line with business plan for post-approval activities.
  • Complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
  • Prepare and compile regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions, and other correspondence in accordance with EU regulations and guidelines.
  • Ensure compliance within the department by ensuring EAME databases (RegPoint, HAQ) are fully maintained.
  • Support the EMEA RA team with consolidated Calls for Information (CFI) and coordinate submission of PSUSA.
  • Ensure responses are submitted in a timely way in line with standard procedures and metrics set by the VP Regulatory Affairs in European Regulatory.
  • Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties (as appropriate).

Requirements:

  • Maintain awareness/knowledge of current regulatory legislation.
  • Ensure regulatory best practice at all times.
  • Monitor changes in the regulatory environment and highlight any potential impact on Kenvue's products.

Customer Service:

  • Act as an ambassador for the Regulatory Affairs department to raise the profile of the team both internally and externally.
  • Represent Regulatory Affairs on cross-functional product/project teams and provide regulatory advice (as appropriate).
  • Interact with Regulatory Agency.

Education:

  • Life sciences or chemistry graduate to honours level or equivalent.

Skills:

  • Work with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives.
  • Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial/strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations, etc.


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