Regulatory Associate – Part-time 2.5 days per week (flexible on days and hours)
6 month contract
Up to £31 per hour PAYE OR £41 per hour Umbrella
To assist in the preparation of the nonclinical content for various global regulatory dossiers for Vaccine products
Specific Accountabilities and Responsibilities
This role will assist in the preparation of Vaccine nonclinical regulatory dossiers including:
· Global CTD dossiers for Marketed Products
· Clinical Trial Applications
Marketed Products: Support for GSK’s extensive portfolio of established Vaccine products via collation and update, where required, of nonclinical regulatory documentation for the purpose of generating dossiers to support a range of global regulatory submissions. This role involves the continued preservation and update of nonclinical components of marketed product dossiers by:
· Responding to requests for Vaccine nonclinical documentation in a timely manner.
· Coordinating and preparing the nonclinical components of Vaccine lifecycle documents.
· Facilitating construction of nonclinical documentation to support applications in China.
· Comprehensive literature/information searches both externally and internally (specified GSK databases).
· Coordination with other disciplines e.g. Nonclinical development experts and CMC regulatory.
· Preparation/review of tabular data summaries and study listings tables for ongoing submission support.
· Other nonclinical regulatory supporting tasks that may be required from time to time.
- Minimum graduate level, with a relevant biologically based scientific background.
- Understanding of the nonclinical content related to in vivo and in vitro testing: i.e. 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.
· Knowledge of nonclinical regulatory requirements [e.g., Common Technical Document (CTD) guidelines] would be preferable but not essential.
· Knowledge of Vaccine drug development would be preferable but not essential.