Senior Regulatory Operations Associate

Rapidly growing Gene Therapy organisation looking a Regulatory Operations professional with a strong background in eCTD formatting to come on board

GBP Rate Highly Competitive Industry Pharmaceuticals & Life Sciences Location UK - England - London Type Permanent Ref JO-1808-916241 Posted 128 days ago

Job Description

Rapidly growing Gene Therapy organisation looking a Regulatory Operations professional with a strong background in eCTD formatting to come on board. You will be joining a highly supportive environment with the responsibility to grow the Operations team greatly and learn how to build Regulatory Operations systems from scratch

Your Responsibilities

  • Formatting, publishing, performing QCs, and transmitting and archiving the regulatory submissions
  • Gathering necessary source documentation for regulatory filings and documenting them appropriately
  • Assisting the Regulatory Leads in drafting and preparing regulatory submission packages
  • Assisting the Regulatory Leads or BLA/MAA Module leads in providing project management support
  • Keeping track of the planning / progress of regulatory submissions, elaborate retro planning and alert for submissions to come
Your Experience
  • Education to Bachelor’s/advanced degree level in a scientific discipline
  • Strong prior experience within regulatory operations and good knowledge of regulatory submissions throughout the medicinal product development as well as CTD format
  • Effective organisational administrative and planning skills
  • Analytical approach to work with excellent attention to detail
  • Ability to work across different projects in a fast-paced environment
 
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