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Regulatory Affairs Associate

Job Title: Regulatory Affairs Associate
Contract Type: Contract
Location: Ware, England
Industry:
Salary: £20 - £30 per hour
Start Date: 2019-07-08
Reference: BH-111639
Contact Name: Gregory Robertson
Contact Email: Gregory.Robertson@nesgt.com
Job Published: July 18, 2019 08:57

Job Description

Job Description

Regulatory Affairs Associate – Medical Device
 

My client, a global pharmaceutical development company are seeking a Regulatory Associate to join their non-clinical regulatory department on a 6 month contractual basis. This is an excellent opportunity for a life sciences graduate to gain industry experience in regulatory affairs.


Regulatory Affairs Associate Responsibilities:

You will be responsible for assisting in the preparation of non-clinical regulatory dossiers, supporting the businesses extensive product portfolio via update of modular non-clinical regulatory documentation, accurate delivery of regulatory dossiers, maintenance of product marketing and clinical trial applications.
  • Preparing clinical trial applications
  • Preparing common Technical Document dossiers for established product
  • Compiling specific CTD components from existing submission documentation
  • Performing comprehensive literature searches
  • Generating non-clinical submission components to support established pharmaceutical products
  • Authoring an coordinating the non-clinical components of regulatory documents
  • Responding to requests for non-clinical components of lifecycle documents
  • Preparing / reviewing of tabular data summaries and study listings tables for on-going submission support.
Regulatory Affairs Associate Key Requirements:
  • Educated to graduate level within a relevant biologically based scientific background
  • Understanding of pharmacology, pharmacokinetics & toxicology related to drug development
  • Excellent written and verbal communication skills, computer literate and competent in the use of Microsoft word