Regulatory Affairs Manager with innovative biopharma company

Jan 04, 2021
Feb 03, 2021
Kathryn Dorsey
Organization Type
Contract Type
Full Time

Would you like to become a part of innovative biopharma company with an exciting, fast-growing pipeline? Are you looking for an opportunity that will allow you to make a difference in the development of lifesaving technologies? Look no further!

My client, a high-tech, clinical stage biopharmaceutical company leading the way in the development of oncology therapeutics, is currently looking for an experienced Regulatory Affairs Manager who will play a key role in the development and execution of regulatory strategies.

Key Responsibilities:

  • Ensure optimal regulatory strategies for worldwide compliance and submissions
  • Author and compile FDA and EU regulatory applications and submissions
  • Lead preparations for meetings with regulatory agencies
  • Communicate with regulatory agencies regarding submission strategies
  • Ensure regulatory documentation is maintained appropriately


  • BSc /MSc degree with at least 2-3 years of experience in regulatory affairs
  • Experience and knowledge working with oncology therapeutics
  • Experience with face to face meetings with the FDA and EMA
  • Ability to write scientific documents
  • Knowledge of GCP and world-wide regulatory requirements relating to assigned area

For a confidential discussion please get in touch with Kate Dorsey by submitting your CV in WORD format at

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