Job Description – Regulatory Associate
LOA - 1 year
Rate Per Hour: £26.41 Via Umbrella / PAYE Option is available
Location: Ware, Hertfordshire
Department: Nonclinical Regulatory
To assist in the preparation of the nonclinical content for various global regulatory dossiers.
- 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.
Specific Accountabilities and Responsibilities
This role will assist in the preparation of nonclinical regulatory dossiers:
- Eurasian Economic Union (EEU) Rebaseline Project
- Marketed Product and Clinical Trial Application support
EEU Rebaseline Project
The timely and accurate delivery of regulatory dossiers for products to be registered in Eastern Economic Union by central review procedure. This role includes
- Data mining existing and historic dossiers and company archives to identify and locate nonclinical studies
- Liaising with Company archive staff to obtain legacy reports
- 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
- Managing literature references
- Preparation of Environmental Risk Assessments (non European) for submission
- Discussing and resolving issues
- Use of multiple Regulatory Information Management systems/databases
Marketed Product and Clinical Trial Applications:
The timely and accurate delivery of regulatory dossiers for the approval and maintenance of product marketing and clinical trials applications must conform to the regulations and guidance of the authority to which the submission is made. This role may assist the efficient production of submission documents such that the correct materials are available at the optimum time by:
- Data mining and compilation of nonclinical study reports from legacy submissions and company archives
- Comprehensive literature/information searches both externally and internally (specified GSK databases).
- Assisting in the authoring and co-ordination of updates to specific nonclinical regulatory submission components
- Preparation/review of tabular data summaries and study listings tables for ongoing submission support.
- Preparation of Environmental Risk Assessments, which are required under the European Medicines Agency Regulation (EMEA/CHMP/ SWP/4447/00) or as requested by a non-European Union Agency to fulfil country specific requirements
- Collaboration with nonclinical development and regulatory departments
- Responding to requests for nonclinical documentation in a timely manner.
- Other nonclinical regulatory supporting tasks that may be required from time to time.