Regulatory Affairs Manager

4 days ago


St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time
Aircraft Regulatory

About the Role: Achieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team.

Job Description: The successful candidate will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management. This includes accountable management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations like variations, notifications, labelling updates, renewals, sunset clause etc across product portfolio.

Main Responsibilities:

  1. Manage post-approval filings and life cycle maintenance supplements of Marketing Authorisations
  2. Maintenance of MIA and WDA including API import registration
  3. Filing strategy and managing submission timelines
  4. Identifying and remediating compliance gaps if any
  5. Gather, consolidate, analyse documentation and submit regulatory filings
  6. Coordinate and prepare written responses to requests for information from regulatory authorities
  7. Monitor status of regulatory applications
  8. Review and assess the regulatory impact of change control/requests for the manufacturing, testing and release of drug substance and drug product
  9. Provide product & regulatory expertise and clarification on RA requirements for post marketing changes and new product introduction
  10. Provide regulatory support to supply chain, commercial teams, QP, QPPV, Quality 3rd Party contract management as necessary
  11. Contribute to the creation, maintenance and continuous improvement of Regulatory processes, policies and systems
  12. Maintain up to date knowledge of Regulatory and Quality Management requirements, as needed to support the contract manufacture of current products and the introduction of new products
  13. Build good working relationships with CMOs and cross-functional teams within the organisation
  14. Supervise assigned team members with respect to management and training
  15. Participate in resource planning and recruitment procedure
  16. Ensure compliance with company policies, procedures and training expectations

About You: To be successful in this role, you should have a salary of approximately £60000 - £80000 per annum. We are looking for someone with understanding of GMP, Quality and Regulatory requirements, communicative and able to work with a range of stakeholders, at all levels, both internally and externally. Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools. Maintaining an awareness of changing regulatory requirements.



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