Regulatory Affairs Specialist

4 weeks ago


St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Achieva Group Limited. The successful candidate will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management.

Key Responsibilities
  • Manage post-approval filings and life cycle maintenance supplements of Marketing Authorisations, including variations, notifications, labelling updates, renewals, and sunset clause.
  • Maintain MIA and WDA, including API import registration.
  • Develop and implement filing strategies and manage submission timelines.
  • Identify and remediate compliance gaps.
  • Gather, consolidate, and analyse documentation for regulatory filings.
  • Coordinate and prepare written responses to requests for information from regulatory authorities.
  • Monitor the status of regulatory applications.
  • Review and assess the regulatory impact of change control/requests for the manufacturing, testing, and release of drug substance and drug product.
  • Provide product and regulatory expertise and clarification on RA requirements for post-marketing changes and new product introduction.
  • Support supply chain, commercial teams, QP, QPPV, Quality 3rd Party contract management as necessary.
  • Contribute to the creation, maintenance, and continuous improvement of Regulatory processes, policies, and systems.
  • Maintain up-to-date knowledge of Regulatory and Quality Management requirements.
Requirements
  • Understanding of GMP, Quality, and Regulatory requirements.
  • Excellent communication and stakeholder management skills.
  • Proficiency in publishing and compilation of eCTD submissions, eCTD validation, and viewing tools.
  • Awareness of changing regulatory requirements.


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