Regulatory Affairs Executive - 73951

Job Ref: J27521
Sector: Clinical
Sub-sector: Biotech/Life Sciences
Job Type: Temporary
Date Added: 06 July 2018
  • Hertfordshire, England, UK
  • Competitive
    HOUR
  • Natasha Rollason

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The role:

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

Responsibilities:

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

Marketing applications (Global)/Established Products: Support for internal extensive portfolio of established products via update of modular nonclinical regulatory documentation for the purpose of generating dossiers to support a range of global regulatory submissions. This role involves the continued preservation and update of nonclinical components of 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.
  • Comprehensive literature/information searches both externally and internally (specified GSK databases).
  • 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.
  • Collaboration with nonclinical development and regulatory groups.

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 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 must conform to the regulations and guidance of the authority to which the submission is made. This role involves the efficient production of submission documents such that the correct materials are available at the optimum time by:

  • Authoring and coordinating the nonclinical components of regulatory documents such as Investigator brochures updates, and EU and US clinical trials applications.
  • Facilitating construction of nonclinical documentation to support applications in China.
  • Responding to requests for nonclinical documentation in a timely manner.
  • Coordinating and preparing the nonclinical components of lifecycle documents.
  • Comprehensive literature/information searches both externally and internally (specified GSK databases).
  • Coordination with other disciplines eg Nonclinical development and CMC, within a matrix team environment.
  • Preparation/review of tabular data summaries and study listings tables for ongoing submission support.

Basic qualifications:

  • Minimum graduate level, with a relevant biologically based scientific background.
  • Understanding of drug development process from early development to lifecycle management.
  • Thorough understanding of pharmacology, pharmacokinetics & toxicology related to drug development

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.

SRG
05/08/2018 10:59:27
GBP .