* 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.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists