Regulatory Affairs Associate 78263

Job Ref: J32624
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 09 July 2019
  • Hertfordshire, England, UK Hertfordshire Hertfordshire UK SG12 0DJ
  • Competitive
  • Natasha Rollason

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My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Associate on an initial 8 month contract to be based in their offices in Hertfordshire.

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 Common Technical Document dossiers for Established Products

* Environmental Risk Assessments

* 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.
  • Comprehensive literature/information searches both externally and internally.
  • 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.
  • Collaboration with nonclinical development and regulatory groups.
  • 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.
  • 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.
  • Coordination with other disciplines e.g. nonclinical development and CMC.
  • Preparation/review of tabular data summaries and study listings tables for ongoing submission support.
  • Other nonclinical regulatory supporting tasks that may be required from time to time.

Skills/Experience required:

- Degree minimum in any life sciences

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

08/08/2019 09:06:56