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Associate Regulatory Affairs

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

Summary:


Responsibilities


* 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.



Requirements


* 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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