CK Group are recruiting for a Regulatory Associate to join a company in the healthcare industry at their R&D site based in Ware initially on a contract basis for 12 months.
- 25.56 per hour Umbrella
Regulatory Associate Role:
Toassist in the preparation of the nonclinical content for various global regulatory dossiers.
- Data mining existing and historic dossiers and company archives to identify and locate nonclinical studies
- Compilation of complete and accurate nonclinical study reports package for onward submission
- Tracking progress of activities and effectively communicating with team and stakeholders to progress collation/preparation and hand over of nonclinical data and documentation
- Collaboration with EEU Rebaseline Team and managing literature references
- Minimum graduate level, with a relevant biologically based scientific background.
- Understanding of the nonclinical content related to in vivo and in vitro testing:ie pharmacology, pharmacokinetics & toxicology related to drug development
- Excellent written and verbal communication skills, computer literate and competent in the use of Microsoft Word and Excel.
- Proficiency in searching on-line scientific publication databases.
Knowledge of nonclinical regulatory requirements [e.g., Common Technical Document (CTD) guidelines] would be preferable but not essential.
Our client is a global healthcare company, taking on some of the world's biggest healthcare challenges.
This Regulatory Associate role will be based at our clients R&D site in Ware, Hertfordshire.
Entitlement to work in the UK is essential. For more information, please contact Heather on 01438 870011 or email email@example.com. Please quote reference 51543.
Please note that the successful applicant will be required to engage via an FCSA-accredited and CK-approved umbrella companyand the rate of pay indicated is an umbrella rate.