Regulatory Associate - Non Clinical

£25 - 30 per hour
Oct 12, 2016
Nov 09, 2016
Peter Duvall
Result Type
Position Type
Full Time

An attractive job opportunity has arisen at a leading multinational pharmaceutical company who are seeking a Regulatory Associate - Non Clinical to work at their UK site in Ware. The company employs 100,000 personnel across 150 countries, working across multiple therapy areas including cardiovascular, oncology, and respiratory.

This job role involves assisting in the preparation of the nonclinical content for various global regulatory dossiers.


Basic qualifications:

  • 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.

Preferred qualifications:

Knowledge of nonclinical regulatory requirements [e.g., Common Technical Document (CTD) guidelines] and/or environmental risk assessments would be preferable but not essential.

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

Established Products: 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.
  • Environmental Risk Assessments: This role will support the 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.
  • 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.
  • 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 Apply:

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 Peter Duvall on 0203 0789 542 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.

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