Director Regulatory Science

4 weeks ago

Stevenage Hertfordshire, United Kingdom Spur Therapeutics Full time

Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work 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. Come join Spur's dedicated team of scientists, physicians and other professionals who are singularly focused on using cutting-edge science and technology to transform the treatment of serious and debilitating chronic diseases.

We are a clinical-stage biotech company developing transformative adeno-associated virus (AAV) vector-mediated gene therapies. Founded in 2015, Spur is focused on developing innovative, one-time treatments that set new standards of care. Our integrated gene therapy platform includes in-house capabilities in research, protein engineering and clinical development, and we optimize every component of our product candidates to develop first- and best-in-class gene therapies. We are currently advancing a highly differentiated gene therapy candidate in a Phase 1/2 clinical trial in people with Gaucher disease. Spur is global, with research facilities and offices in Stevenage, UK, and offices in Boston and New York.

We are relentless in our pursuit of transformative medicines for patients. We take innovation seriously and know we need to be bold both in our science and in every aspect of our work. This is a hybrid role based at the Stevenage, UK or Boston, MA office location. Director Regulatory CMC is responsible for overseeing the development and implementation of global regulatory CMC strategies for assigned Spur global gene therapy programs, including those both in the clinic and in development. The position will provide strategic and operational leadership for regulatory CMC activities, interfacing with CMC, Clinical, and Clin Reg teams. Functions include CMC regulatory strategy, submission generation in tandem with CMC, submission reviews, and health authority interactions. We are also actively establishing a new CDMO for the phase 3 asset. 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 including providing strategic regulatory input into the structure and content of briefing documents
Provides strategic regulatory input into the structure and content of 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
Provides CMC regulatory representation to relevant sub-teams such as CMC teams and regulatory teams
Collaborates with cross-functional colleagues to ensure consistency of approach to CMC regulatory challenges across the portfolio/platform
Leads CMC regulatory meetings, ensuring appropriate input from SMEs and ensuring advice and commitments are clear
Maintains an awareness of CMC development activities to ensure regulatory aspects are appropriately considered
Maintains an awareness of CMC regulatory guidance and intelligence and ensures this is considered in project CMC strategy

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
Experience of developing process control strategies in line with regulatory expectations
Detailed knowledge of CMC regulatory requirements throughout development and registration
Demonstrable experience of providing strategic regulatory input to CMC strategy
Experience of participating in and leading preparation for, regulatory meetings
Proficient user of common business computer packages, collaborative tools and RIMS
Ability to manage multiple activities, respond to changing business demands and deliver to short timelines
Ability to make strategic decisions with respect to CMC regulatory content and strategy
Ability to travel to meetings in Europe, US or further afield as the role requires

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