Director of Regulatory Affairs

1 week ago


Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

Gene therapy is at a pivotal point. Amidst the plethora of emerging modalities, we've been refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives.

About Us

We are a clinical-stage biotech company dedicated to developing transformative adeno-associated virus (AAV) vector-mediated gene therapies. Founded in 2015, we're focused on developing innovative, one-time treatments that set new standards of care.

Our Vision

We optimize every component of our product candidates to develop first- and best-in-class gene therapies. Our integrated gene therapy platform includes in-house capabilities in research, protein engineering, and clinical development.

Role Overview

This is a hybrid role based at the Stevenage, UK or Boston, MA office location. The Director Regulatory CMC will oversee the development and implementation of global regulatory CMC strategies for assigned Spur global gene therapy programs.

Responsibilities

  • Develops CMC regulatory strategy for Spur development-phase projects, including identifying potential regulatory challenges and strategies for managing regulatory risk
  • Works with CMC to define topics for scientific advice interactions and leads meeting preparation
  • Provides strategic regulatory input into core CMC regulatory documents and provides regulatory review of content
  • Ensures appropriate cross-functional input to CMC regulatory questions and works with cross-functional colleagues to respond to regulatory questions in a timely manner
  • Contributes overall project strategy via membership of the project teams

Requirements

  • Strong scientific background, preferably in Biological Sciences or Pharmacy/Chemistry
  • At least 10 years' experience of working in CMC regulatory disciplines in a pharmaceutical/biotech company
  • Detailed knowledge of CMC regulatory requirements throughout development and registration
  • Excellent communication and interpersonal skills and ability to work collaboratively in matrix teams

Estimated salary: $120,000 - $150,000 per annum, depending on qualifications and experience.



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