Regulatory Associate
- Ware, (GBR)
- £16 - £18.3 Per Hour
- 3 Months
- Start date: ASAP
- Ref: GSK0JP00104650
- regulatory submissions
- drug development
- documentation
- toxicology
- in vitro
- publishing
- reports
- pharmacology
- records management
- vaccines
Regulatory Associate
Department: Nonclinical Regulatory
9 Months – ASAP Start
Ware – Hybrid Working
£18.30p/h – Full Time 37.5 Hours per Week
Role Brief:
To assist in the preparation of the nonclinical pharmacology, pharmacokinetics & toxicology content for global regulatory dossiers.
Basic qualifications:
• 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
Preferred qualifications:
Knowledge of nonclinical regulatory requirements [e.g., Common Technical Document (CTD) guidelines] would be preferable but not essential.
Capabilities
• Excellent written and verbal communication skills
• Competent in the use of Microsoft Word and Excel
Specific Accountabilities and Responsibilities
This role will support GSK’s extensive portfolio of marketed medicines and vaccines products, managing multiple products in parallel; aligned to departmental priorities and timelines. It is a document management role involving cross checking nonclinical regulatory submission dossiers and supporting documentation. The objective is to ensure availability of submission ready, nonclinical study reports in preparation for a whole series of regulatory submissions including;
• Market specific rebaseline dossiers
• Licence Renewals
It will involve close collaboration line management and with other departments, to successfully deliver and report on availability of historical nonclinical documentation, to support future regulatory submissions.
Activities include:
• Reviewing and cross checking nonclinical summary documentation with currently available supporting data
• Data mining of nonclinical study reports from the company and submission archives
• Collaboration with Records Management and Archiving responsible for historical nonclinical reports.
• Facilitating upload of nonclinical reports to current systems in a submission ready state.
• Collaboration with Nonclinical Publishing responsible for managing historical study reports into current systems.
• Quality Checks
• Preparation of status reports in relation to nonclinical studies to facilitate future submission preparation
• Collation and hand-off of nonclinical summaries and reports to support regulatory submissions
• Collaboration with regulatory content delivery departments
• Active, regular participation in meetings to discuss status and prioritization of activities and issues
• Update of appropriate tracking/scheduling documentation
• Other nonclinical regulatory supporting tasks that may be required from time to time.
