Senior Director Regulatory CMC Lead
3 weeks ago
We're at an inflection point in gene therapy, with emerging modalities pushing the boundaries of what's possible. As a Senior Director Regulatory CMC Lead at Spur Therapeutics, you'll play a crucial role in developing transformative adeno-associated virus (AAV) vector-mediated gene therapies.
About the RoleThis hybrid position is based at our Stevenage, UK or Boston, MA office location. You'll oversee global regulatory CMC strategies for assigned Spur gene therapy programs, including those in the clinic and development. Your expertise will provide strategic and operational leadership for regulatory CMC activities, interfacing with CMC, Clinical, and Clin Reg teams.
Key Responsibilities:- Develops CMC regulatory strategy for Spur projects, identifying potential regulatory challenges and strategies for managing regulatory risk.
- Works with CMC to define topics for scientific advice interactions and leads meeting preparation, providing strategic regulatory input into briefing documents.
- Provides strategic regulatory input into core CMC regulatory documents and reviews content.
- Ensures cross-functional input to CMC regulatory questions and responds to regulatory questions in a timely manner.
- Contributes overall project strategy via project team membership.
- Represents CMC in relevant sub-teams, such as CMC and regulatory teams.
- Collaborates with colleagues to ensure consistency of approach to CMC regulatory challenges across the portfolio/platform.
- Leads CMC regulatory meetings, ensuring SME input and clear advice and commitments.
- Strong scientific background, preferably in Biological Sciences or Pharmacy/Chemistry.
- At least 10 years' experience in CMC regulatory disciplines in a pharmaceutical/biotech company.
- Knowledge of CMC development requirements for biologics registration, including manufacturing processes and analytical strategies.
- Experience in developing process control strategies in line with regulatory expectations.
- Detailed knowledge of CMC regulatory requirements throughout development and registration.
- Demonstrable experience in providing strategic regulatory input to CMC strategy.
- Experience in participating in and leading regulatory meetings.
The estimated salary for this position is $120,000 - $180,000 per year, depending on experience.
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