Asklepios BioPharmaceutical, Inc. (AskBio)

Compliance

• Support innovative, comprehensive regulatory CMC strategies and associated timelines for assigned projects to ensure timely global registration of Company’s product candidates in gene therapy
• Manage and implement planning, authoring and submission of high-quality CMC‑related sections of briefing documents and clinical trial applications in the US, EU and ROW
• Provide general operational support to RA CMC team across all programs, including submission management, regulatory project management, and Veeva technical support
• Prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections
• Drive adherence to CMC regulatory guidelines relevant for the development of gene therapy products; author, review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
• Support the development of regulatory processes and standards
• Ensure operational alignment and on-time completion of all registration-directed activities through close collaboration with Project Management colleagues and senior management
• Partner with Quality Assurance colleagues to ensure regulatory compliance with applicable local and international laws and regulations, as well as industry standards.

Associate Director, Regulatory Affairs, CMC