ProClinical is currently recruiting for a regulatory affairs job on behalf of a top 10 global pharmaceutical company located in Hertfordshire on a contract basis. Our client has a vacancy for a Regulatory Affairs Associate to assist in the preparation of the nonclinical content for various global regulatory dossiers. This role will be on a 12-month contract with the possibility to extend.
Skills and Requirements:
- Minimum graduate level, with a relevant biologically based scientific background. - pharmacology/ biomedical science/ toxicology/ life sciences
- Excellent written and verbal communication skills, computer literate and competent in the use of Microsoft Word.
- Proficiency in searching on-line scientific publication databases.
- Knowledge of nonclinical regulatory requirements [e.g., Common Technical Document (CTD) guidelines] and/or environmental risk assessments would be preferable but not essential.
- 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 (IBs)
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Numhom Sudsok on or upload your CV on our website - .
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.