Job DescriptionJob Description
Regulatory Affairs Associate – Medical Device
My client, a global pharmaceutical development company are seeking a Regulatory Associate to join their non-clinical regulatory department on a 6 month contractual basis. This is an excellent opportunity for a life sciences graduate to gain industry experience in regulatory affairs.
Regulatory Affairs Associate Responsibilities:
You will be responsible for assisting in the preparation of non-clinical regulatory dossiers, supporting the businesses extensive product portfolio via update of modular non-clinical regulatory documentation, accurate delivery of regulatory dossiers, maintenance of product marketing and clinical trial applications.
- Preparing clinical trial applications
- Preparing common Technical Document dossiers for established product
- Compiling specific CTD components from existing submission documentation
- Performing comprehensive literature searches
- Generating non-clinical submission components to support established pharmaceutical products
- Authoring an coordinating the non-clinical components of regulatory documents
- Responding to requests for non-clinical components of lifecycle documents
- Preparing / reviewing of tabular data summaries and study listings tables for on-going submission support.
- Educated to graduate level within a relevant biologically based scientific background
- Understanding of pharmacology, pharmacokinetics & toxicology related to drug development
- Excellent written and verbal communication skills, computer literate and competent in the use of Microsoft word