Catalyst

Home / Jobs / Regulatory CMC specialist

Regulatory CMC specialist


  Remote,   Competitive hourly rate

Apply Now

  Regulatory Affairs    Contract

This is the opportunity to join an international organisation for an urgent Regulatory CMC contract based remotely. You will be required for 20 hours per week helping to lead on regulatory submissions.

Responsibilities:

  • Lead regulatory submissions teams and design regulatory strategy on biologics/pharma projects.
  • Drafting, reviewing, editing and compiling submission documents in eCTD format.
  • Collaboration with regional and global teams to develop regulatory strategy.
  • Ensure compliance with EU requirements e.g. cGMP, GDP, GDocP and GCP.
  • Deliver training in technical writing and critical thinking.

Requirements:

  • Bachelor's degree or equivalent in chemistry, biology or natural sciences.
  • 7+ years' experience working in pharma/biopharma industry and with submissions.
  • Several years' experience with cGMP, GDP, GDocP.
  • Detail-oriented and proficient at reviewing and editing documents.
  • Immediately available.

If you, or someone you know are interested please send your CV across to .

Joe.Lane

  Apply with Linkedin   Apply with Indeed