Regulatory Affairs Associate

Highly Competitive
  1. Permanent
  2. Officer /Associate
  3. United Kingdom
Hertfordshire
Posting date: 16 Jul 2019
RA.NS.24345_1563288952

A top 10 global pharmaceutical company is currently recruiting a Regulatory Affairs Associate. This organisation develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally. Based in the company's office in Hertfordshire, this position offers an exciting opportunity to work with an internationally renowned company and bolster a career in the regulatory field.

Job Responsibilities:

  • Assisting in the preparation of nonclinical regulatory dossiers including:
    • Global CTD dossiers for Established Products
    • Clinical Trial Applications
  • Providing support for the company's 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.
  • Completing periodic updates of the documents to ensure that they reflect a contemporary understanding of each product.
  • Compiling specific CTD components from existing submission documentation.
  • Implementing comprehensive literature/information searches both externally and internally.
  • Where necessary, technically authoring new CTD components to support in licensed/collaborative products.
  • Generating nonclinical submission components to support established pharmaceutical products, e.g. Label unification and ad hoc requests for information.
  • Collaborating with nonclinical development and regulatory groups.
  • Ensuring that the timely and accurate delivery of regulatory dossiers for the approval and maintenance of product marketing and clinical trials applications conform to the regulations and guidance of the authority to which the submission is made.
  • 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.
  • Coordinating with other disciplines, e.g. Nonclinical development and CMC.
  • Preparing/reviewing 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 and Requirements:

  • Minimum graduate level, with a relevant biologically based scientific background.
  • Understanding of pharmacology, pharmacokinetics, and toxicology related to drug development.
  • Proficiency in searching on-line scientific publication databases.
  • Knowledge of nonclinical regulatory requirements [e.g., Common Technical Document (CTD) guidelines] and/or Clinical Trials Applications.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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 contact Numhom Sudsok at +44 203 871 8093 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.

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