Regulatory Affairs Associate - 73934

Job Ref: J27520
Sector: Clinical
Sub-sector: Biotech/Life Sciences
Job Type: Temporary
Date Added: 06 July 2018
  • Hertfordshire, England, UK
  • Competitive
  • Natasha Rollason

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The Role:

To assist in the preparation of the nonclinical content for various global regulatory dossiers. 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

Key Responsibilities:

  • 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.
  • 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.

Skills/Experience Required:

Basic qualifications: Minimum graduate level, with a relevant biologically based scientific background.

Knowledge of pharmacology, pharmacokinetics and toxicology related to drug development is essential.

If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 589673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

05/08/2018 10:43:43