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Associate Regulatory Affairs

Quality & Laboratory
Dublin South
Siobhán Lane
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Job Reference: JO-2008-65360_1598624522



* Registration document(s) procurement, preparation, coordination submission and archival

* Coordinates legalization and delivery of registration documents following the instructions provided in the request.

* Maintains tracking and organization of documentation, including uploading in CSD tool or other document repository.

* Supports the Site Regulatory CMC Team in the compilation and preparation of marketing application and post-approval submissions as needed.

* Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.


* Bachelor/Master's degree (Regulatory, Life Sciences, Biotechnology or related discipline)

* 2 years' relevant experience

* Candidates must have GMP site experience, with some sort of reg experience

* Basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS)

* Proficient use of MS Office tools, SharePoint and strong computer aptitude.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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