CMC Regulatory Affairs (RA) Associate Director

Position

CMC Regulatory Affairs (RA) Associate Director

Direct Report

Position Summary

Under I-Mab US office, this position is reporting to the Director of Regulatory Affairs and will be responsible for the implementation of regulatory CMC strategy in support of overall regulatory CMC activities, from early phase clinical through marketing applications for multiple projects and teams simultaneously. This position will also provide support for the delivery of high-quality regulatory submissions, including directly preparing submission content and managing submission project deliverables and timelines.

Key Responsibilities

  • Lead the development, implementation, and execution of regulatory CMC strategy
  • Ensure all regulatory submissions and CMC projects align with defined regulatory strategy and proactively identify gaps/work with teams to develop mitigation proposals
  • Work in cross-functional matrix project teams in regulatory, chemical, and pharmaceutical development and manufacturing areas
  • Maintain high quality standards and raise performance through continuous improvement in the evolving regulatory environment
  • Lead initiatives for project and timeline management in support of regulatory CMC objectives and projects
  • Actively participate/lead regulatory CMC infrastructure and capability building, including developing best practices, training tools, and cross-program learning
  • Represent regulatory CMC in co-operative multi-disciplinary meetings/forums

Qualifications

  • Ph.D. degree in Chemistry, Biochemistry, or related pharmaceutical science required
  • 6 or more years of direct CMC regulatory experience in pharmaceutical industry or regulatory agency
  • Sound understanding of chemistry/biochemistry for biological products. Experience with mRNA products is a plus
  • General knowledge of US regulatory framework, with demonstrated understanding of US FDA regulatory requirements and guidance as applicable within technical expertise area
  • Demonstrated ability to work effectively both independently and in a collaborative/team environment, with the flexibility and strength to navigate high-stress situations with multiple disciplines and personalities
  • Demonstrated strong organizational skills, including ability to prioritize work tasks across multiple projects and timelines. Direct project management experience is a plus