Post Approval Change Manager

2 weeks ago


St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time
About the Role

This is an exciting opportunity to join Achieva Group Limited as a Regulatory Affairs Manager. The successful candidate will be responsible for post approval changes of Marketing Authorisations and product life cycle management.

As a member of our team, you will play a key role in ensuring that our products meet the necessary regulatory requirements. Your duties will include the management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations, including variations, notifications, labelling updates, renewals, and sunset clause across the product portfolio.

Duties
  • Maintenance of MIA and WDA, including API import registration.
  • Filing strategy and managing submission timelines.
  • Providing product & regulatory expertise and clarification on RA requirements for post marketing changes and new product introduction.
Requirements
  • Required Skills:
    • Understanding of GMP, Quality and Regulatory requirements.
    • Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools.
  • Estimated Salary: £60,000 - £80,000 per annum.


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