Regulatory Affairs Associate

Posted 7 March by PE Global

PEGlobal are looking for a Regulatory Affairs Associate for our multinational bio-pharmaceutical client based in the Middlesex area on an initial 12 month contract

Main Responsibilities of the role

  • The Regulatory Professional will assist in the creation and submission of regulatory documents. 
  • Collect and / or create country specific document for regulatory filings worldwide 
  • Assist Regional Regulatory Lead to support pre-filing activities (e.g. core CTA/IMPD support or pre-MAA filing) 
  • Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments) in collaboration with Regional Regulatory Lead
  •  Create and maintain product regulatory history documents through IMR/GRIP and appropriately archive all regulatory documents and agency communications 
  • Ensure compliance via timely submissions to regulatory agencies
  • Coordinate collection of functional documents in support of regulatory applications
  •  As appropriate, participate in GRT to support execution of regulatory strategy. Respond to specific requests from and communicate relevant issues to GRT
  •  Support process improvement initiatives, standards development, and metrics Assist in template development and maintenance 
  • Actively support regulatory compliance 
  • Support the development and execution of GRT goals 

Desired Experience and Skillset of the successful candidate

  • Strong communication skills - oral and written
  • Organizational skills; Understanding of drug development process
  • knowledge of CMC requirements, especially country specific documents for international filings
  • Ability to multi-task in a fast paced environment

Reference: 34629839

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