Post-Marketing Change Coordinator

2 weeks ago


St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time
Achieve Excellence in Regulatory Affairs

We are seeking a talented individual to join our Achieva Group Limited team as a Post-Marketing Change Coordinator.

Key Responsibilities: The ideal candidate will be accountable for management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations. This includes tasks such as maintenance of MIA and WDA including API import registration, filing strategy and managing submission timelines, identifying and remediating compliance gaps if any, gather, consolidate, analyse documentation and submit regulatory filings, coordinate and prepare written responses to requests for information from regulatory authorities, monitor 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.

About Your Background: To excel in this role, you will need to have a salary of around £65000 - £85000 per annum. A strong understanding of GMP, Quality and Regulatory requirements is essential, along with excellent communication skills and ability to work with diverse stakeholders. Additionally, proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools is required. Staying up-to-date with changing regulatory requirements is also crucial.



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