QC Systems Investigations/Change Control- 12 months contract DublinSRG are a strategic recruitment partner to a global pharmaceutical company who are looking for QC Systems Associate...
Regulatory Affairs Associate - 12 months contract - Dublin
SRG are a strategic recruitment partner to a global pharmaceutical company who are looking for Regulatory Affairs Associate to join the team in Dublin.
- 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.
- Knowledge of Good Manufacturing Practices (GMP) and good documentation practices
- The applicant should have basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS)
- Proficient use of MS Office tools, SharePoint and strong computer aptitude.
- Solid working knowledge on document management systems such as Documentum.
Bachelor's degree or higher in Regulatory, Life Sciences, Biotechnology or related discipline. A minimum of 4 years of related pharmaceutical industry experience.
To apply for this position, please apply online or email a copy of your CV camila.lanzillo @srg.co.uk
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