Regulatory Affairs Associate
This job is a great opportunity for a Regulatory Affairs Associate to work at one of the top 10 global pharmaceutical companies. This role will be based at the company’s office in Hertfordshire, UK. The organisation develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally.
This role will provide support for the company's extensive portfolio of established products via update of a repository of modular nonclinical regulatory documentation, stored within a document management system for the purpose of generating dossiers to support a wide range of regulatory submissions. The position involves the continued preservation and updating of the established product dossiers by:
- 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 eg Label unification, ad hoc requests for information.
Clinical Trial Applications: The timely and accurate delivery of regulatory dossiers for the approval and maintenance of product marketing and clinical trials applications is a business critical activity. Regulatory submission documents (paper or electronic) must conform to the regulations and guidance of the authority to which the submission is made, the efficient production of submission documents such that the correct materials are available at the optimum time requires a wide range of operational support activities:
- 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 eg Nonclinical development and CMC.
- Preparation/review of tabular data summaries and study listings tables for ongoing submission support
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
Education and Experience:
- Minimum graduate level, with a relevant biologically based scientific background.
- 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.
- Specific Accountabilites and Responsibilites
If you are interested in applying, please click the Apply button. Please include a short note detailing why you are interested and how you are suitable for the role.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical devices companies.
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