Regulatory Affairs Specialist

3 weeks ago

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

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at eTeam. As a key member of our Regulatory Affairs department, you will be responsible for managing post-approval activities for specified OTC products.

Key Responsibilities:

  • 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.
  • Develop regulatory strategies, prepare 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.
  • Support the team to 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 Marketing Authorisations are maintained and renewed.
  • Ensure compliance within the department by ensuring EAME databases (RegPoint, HAQ) are fully maintained.
  • Process, SOPs, working instructions, and Job Aids are adhered to.
  • Update relevant document repositories (e.g CEDMS, Teams etc.) to track current product information.
  • Support the EMEA RA team with consolidated Calls for Information (CFI) and coordinate submission of PSUSA.
  • Review and comment consolidated CFI received from CGRRMB to ensure accurate information is sent to Aggregate report writer.
  • Ensure responses are submitted in a timely way in line with standard procedures and metrics set by the VP Regulatory Affairs in European Regulatory.
  • Review draft and final PSUR.
  • Coordinate submission of PSUSA and ensure on-time submission.
  • Coordinate all steps of PSUSA following its submission until CMDh position is received.
  • Coordinate submission of post-PSUSA variation across EEA as per SOP and WI.
  • Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties (as appropriate).

Requirements:

  • Life sciences or chemistry graduate to honours level or equivalent.
  • Works with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives.
  • Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
  • 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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