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Quality Consultant
3 months ago
Our client, an independent pharmaceutical company who specialise in the development and manufacture of specialist medicine and generics, have an opportunity for a European experience Regulatory Lead to join their team in Hampshire on a 12-month FTC.
As Regulatory Affairs Consultant, you will have the below responsibilities:
You will perform the necessary regulatory tasks with data and documentation review, submission execution - to obtain new Marketing Authorisations in UK (GB/NI) for both generic and innovative products.
Ensure technical dossiers are aligned and optimised with EU Regulatory data requirements for new EU Marketing Authorisation Applications and post approval variations, where required
Perform the necessary regulatory activities for your assigned projects from pre-submission until post-approval handover to regulatory maintenance teams. This includes review and optimisation of dossier content (particularly Module 3), compilation and submission of files, resolution of Health Authority questions in cooperation with other functions, and submission of variations where required
Communicate regulatory information for assigned projects before, during and after approval and provide regulatory support to project teams, stakeholders, and customers, as required
Track and monitor queries/deficiency letters/commitments from/to European Health Authorities to ensure these are implemented and conformed in compliance with.
To be considered for the Regulatory Affairs Consultant FTC, you will have the following:
Minimum 3 years Regulatory Affairs experience ideally with medicines, medical devices, OTCs
This is an FTC, Hybrid working from our clients Hampshire office.
