An internationally known pharmaceutical company situated in Hertfordshire, UK and operating in over 150 markets worldwide is looking to hire a Regulatory Associate. The company develops a broad range of products in pharmaceuticals, vaccines and consumer healthcare.
This Regulatory Associate 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.
- 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.
- Preparation of ERA documents which are required under the European Medicines Agency Regulation on Marketing Authorization Applications (MAAs), product line extensions, and license variations (EMEA/CHMP/ SWP/4447/00) or as requested by a non-European Union Agency to fulfil country specific requirements.
- 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.
- 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 (specified company databases)
- Coordination with other disciplines e.g. Nonclinical development and CMC.
- Preparation/review of tabular data summaries and study listings tables for ongoing submission support.
- To perform such other tasks for which qualified by reason of educational attainment, training or experience as from time to time may be required by NCR management.
- To assist in the preparation of the nonclinical content for various global regulatory dossiers.
- 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.
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 Elise Lambeth on +44 207 4400 633 or upload your CV on our website www.proclinical.com.
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.