Global Regulatory Compliance Officer

4 days ago


Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time
Sr. Director Regulatory CMC Job Description

This Sr. Director Regulatory CMC position is a key role within our organization, responsible for overseeing global regulatory CMC strategies for assigned Spur gene therapy programs. If you have a strong scientific background and at least 10 years of experience in CMC regulatory disciplines, we encourage you to apply for this exciting opportunity.

About Us

Spur Therapeutics is a clinical-stage biotech company developing transformative adeno-associated virus (AAV) vector-mediated gene therapies. Our integrated gene therapy platform includes in-house capabilities in research, protein engineering, and clinical development, optimizing every component of our product candidates for first- and best-in-class gene therapies.

Job Requirements:
  • Bachelor's degree in a related field, such as Biological Sciences or Pharmacy/Chemistry.
  • At least 10 years of experience in CMC regulatory disciplines in a pharmaceutical or biotech company.
  • Strong understanding of CMC development requirements for biologics registration, including manufacturing processes and analytical strategies.
  • Ability to develop process control strategies in line with regulatory expectations.
  • Detailed knowledge of CMC regulatory requirements throughout development and registration.

The estimated salary for this position is $120,000 - $180,000 per year, depending on experience.



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