Global Regulatory CMC Lead

Job Description

The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets in development, prepares CMC sections of IND/IMPD, MAA, NDA/BLA as well as assesses global filing strategy for post approval changes.

The role holder works closely with Global Manufacturing Sciences subject matter experts, Quality representatives, and cross‑functional stakeholders in Regulatory Affairs. The Global Regulatory CMC Lead also supports Global Manufacturing and Supply where R&D deliverables are needed for regulatory submissions.

Key Responsibilities

• Develop global regulatory CMC strategies to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which include CMC information
• Write and compile CMC sections of regulatory submissions including clinical trial applications and variations/supplements as well as...