Marketing Authorization Specialist

1 week ago


St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time
Succeed as a Marketing Authorization Specialist

Achieva Group Limited is hiring a dedicated Marketing Authorization Specialist to oversee post-approval changes of Marketing Authorisations and product life cycle management.

Main Tasks: The selected candidate will manage post-approval filings and life cycle maintenance supplements of Marketing Authorisations, including 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.

Your Qualifications: To succeed in this position, you should possess a salary of approximately £70000 - £90000 per annum. A solid understanding of GMP, Quality and Regulatory requirements is vital, along with exceptional communication skills and ability to interact with various stakeholders. Moreover, proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools is necessary. Keeping abreast of evolving regulatory requirements is also essential.



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