Regulatory Affairs Specialist

2 days ago


St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time
Job Title: Regulatory Affairs Specialist

 Achieva Group Limited is seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management.

About the Role

The successful candidate will be accountable for the management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations across our product portfolio. This includes variations, notifications, labelling updates, renewals, and sunset clause etc. They will also be responsible for maintaining MIA and WDA, including API import registration, and developing filing strategies and managing submission timelines.

In addition, the Regulatory Affairs Specialist will identify and remediate compliance gaps, gather, consolidate, and analyse documentation, and submit regulatory filings. They will also coordinate and prepare written responses to requests for information from regulatory authorities, monitor the status of regulatory applications, and review and assess the regulatory impact of change control/requests for the manufacturing, testing, and release of drug substance and drug product.

The ideal candidate will have excellent communication skills and be able to work with a range of stakeholders, both internally and externally. They should have proficiency in publishing and compilation of eCTD submissions, eCTD validation, and viewing tools, as well as an awareness of changing regulatory requirements.

This is a rewarding opportunity to join a dynamic team and contribute to the creation, maintenance, and continuous improvement of Regulatory processes, policies, and systems.

We offer a competitive salary of $120,000 - $150,000 per annum, depending on experience, plus benefits.



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