Senior Director, CMC Regulatory Affairs
August 30
🏢 In-office - San Francisco
Description
• Provide strategic CMC regulatory leadership to develop and execute sound regulatory strategies that meet global regulatory requirements and enable Vir business objectives. • Provide CMC regulatory expertise to enable global development and registration for INDs, CTAs, BLAs and MAAs. • Identify and communicate regulatory risks and facilitate the development and execution of risk mitigation strategies in concert with Technical Operation functions. • Plan strategy for and lead HA interactions for CMC specific issues. • Manage CMC regulatory changes throughout the product life cycle, including support for relevant quality systems related to change control, discrepancy management, as well as Health Authority inspection support as required. • Ensure overall compliance with regulatory requirements. • Ensure compliance with internal SOP's and policies regarding regulatory operations, document management. • Contribute to regulatory excellence by identifying opportunities and supporting continuous improvement.
Requirements
• B.S., M.S., Ph.D. or other relevant advanced degree or certificate. • 12+ years experience in pharmaceutical product development including strong global Regulatory CMC leadership. • Regulatory CMC experience leading both development projects (IND/CTA) and initial registration (BLA/MAA). • Experience with CMC regulatory considerations for late stage and/or commercial large molecules (biologics) is required; experience with combination products is a plus. • Proven track record of successful Health Authority interactions is preferred. • Thorough understanding of major FDA, EMA, ICH guidelines. • Global filing experience (US, EU, CA, Aus, NZ). Working knowledge of Japan, China, LATAM procedures a plus. • Excellent written and verbal communication with strong track record of collaboration. • Ability to effectively present to and influence Senior Management. • This role is located in San Francisco at our corporate office
Benefits
• health, dental, vision, life and disability insurance benefits • non-accrual paid time off • company shut down for holidays • commuter benefits • child care reimbursement • education reimbursement • 401K match • lunch for all onsite employees!
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