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Senior Regulatory Affairs Associate Cmc

3 months ago

Liverpool, Liverpool, United Kingdom Thornshaw Scientific Recruitment Full time
Posted date 01 February 202- LocationMerseyside

  • Job type Contract
  • SalaryNegotiable
  • Discipline Life Sciences
  • ReferenceJO
  • Work Location Hybrid
Regulatory Affairs Senior Associate

6 month contract

Liverpool based - Hybrid working with 3 days onsite

Offering up to £40.00 Per Hour via PAYE

Strong potential for extension


CPL Life Sciences is collaborating with a leading pharmaceutical firm, whose core focus is the continued development of the influenza vaccine.

Our client is looking for a Senior Regulatory Affairs Associate within CMC initially on a 6 month contract to be based from their Liverpool site.

Working within the CMC and Compliance team, you will be contributing to the implementation of global and regional objectives by leading and executing the CMC strategy for multiple products.

Core Responsibilities include;

  • Lead and assist in the development and implementation of the global CMC regulatory strategy
  • Lead the authoring, preparing and compiling of high quality, submissionready CMC documentation for HA submissions
  • Ensure compliance of CMC regulatory dossiers with manufacturing and quality control processes
  • Support global CMC regulatory and change control policies and procedures
  • Eligibility to live and work in the United Kingdom
  • A Life Sciences degree or equivalent
  • Up to 2 years experience within Regulatory experience
  • Able to work on site 3 days per week
  • Experience working in a CMC environment is advantageous not a requirement
  • Prior experience supporting UK and EU Affiliates is a benefit
  • Able to work on site 3 days per week