The Role:To assist in the preparation of the nonclinical content for various global regulatory dossiers. This role will assist in the preparation of nonclinical regulatory...
To assist in the preparation of the nonclinical content for various global regulatory dossiers. This role will assist in the preparation of nonclinical regulatory dossiers including:
* Global CTD dossiers for Established Products
* Environmental Risk Assessments (ERA)
* Clinical Trial Applications
- Completion of periodic updates of the documents to ensure that they reflect a contemporary understanding of each product
- Compilation of specific CTD components from existing submission documentation
- Where necessary, technical authoring of new CTD components to support in licensed/collaborative products.
- Generation of nonclinical submission components to support established pharmaceutical products e.g. Label unification, ad hoc requests for information.
- Authoring and coordinating the nonclinical components of regulatory documents such as Investigator brochures updates.
- Facilitate construction of non-clinical documentation to support applications in China
- Responding to requests for non-clinical documentation in a timely manner
- Coordinating and preparing the nonclinical components of lifecycle documents
- Comprehensive literature/information searches both externally and internally
- Coordination with other disciplines e.g. Nonclinical development and CMC.
- Preparation/review of tabular data summaries and study listings tables for ongoing submission support.
Basic qualifications: Minimum graduate level, with a relevant biologically based scientific background.
Knowledge of pharmacology, pharmacokinetics and toxicology related to drug development is essential.
If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.