Head of Regulatory Affairs

1 day ago


St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full time
About the Role

This exciting opportunity is ideal for a seasoned Quality professional looking to take on a leadership position in a growing pharmaceutical manufacturer.

Responsibilities:

  1. Continuously review and improve the quality management system to ensure compliance with regulatory requirements.
  2. Verify product quality and ensure adherence to GMP regulations.
  3. Lead the team in reviewing third-party audit reports, annual product quality reviews, and complaints.
  4. Host MHRA inspections and ensure compliance with GMP and manufacturing licenses.
  5. Develop and maintain technical files and design dossiers to ensure regulatory compliance.
  6. Stay up-to-date with regulatory changes and best practices in compliance control.
  7. Approve specifications, sampling instructions, test methods, and QC procedures.
  8. Monitor suppliers and ensure compliance with GMP regulations.

Requirements:

  • Strong leadership skills.
  • Excellent communication and problem-solving skills.
  • Proven experience in quality assurance and compliance.
  • Knowledge of GMP regulations and industry standards.
  • Ability to work independently and as part of a team.

What We Offer:

  • A competitive salary range of £80,000 - £120,000 per annum.
  • A comprehensive benefits package.
  • The opportunity to work with a leading pharmaceutical manufacturer.
  • A challenging and rewarding role with opportunities for career growth.


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