SRG are currently looking for Regulatory Associate for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 12 Month basis to be based at their office in Ware.
A Regulatory Associate will assist in the preparation of the nonclinical content for various global regulatory dossiers.
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
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.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: email@example.com or +441615077288
your application has been submitted