Manager, Global Regulatory Affairs - CMC

About this role

Responsibilities

• Plan, prepare, and revise eCTD Module 2.3 and Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements, and variation submissions
• Ensure Module 3 documentation is planned, tracked, and written using regulatory domain systems (Veeva)
• Stay current with evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives, and Annexes
• Collaborate with internal stakeholders including Quality Assurance, CMC/Manufacturing, and preclinical teams for regulatory submissions
• Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes