Global Regulatory CMC Lead – Biologics/ADC (Remote/Hybrid)

Ledgent Technology; Boston (MA); Hybrid; USD 138,000 - 234,000; Full time

Job summary

Ledgent Technology seeks a Senior Regulatory CMC Lead to drive global regulatory CMC strategy for biologic programs from Boston. The role leads MAA/BLA submissions with emphasis on Module 3, coordinating global teams and regulatory submissions.

The ideal candidate has a decade of regulatory affairs CMC experience in biotech/pharma, strong knowledge of FDA/EMA guidelines, and proven ability to manage complex regulatory strategies in a global matrix organization.

Qualifications

• Minimum 10 years in Regulatory Affairs CMC in biotech/pharma.
• Proven leadership of Module 3 for biologic MAA/BLA submissions.
• Strong expertise in biologics and global regulatory requirements (FDA/EMA).

Responsibilities

• Lead global Regulatory CMC strategy for biologic ADC programs.
• Oversee CMC aspects of MAA/BLA submissions and Module 3 content.
• Coordinate health authority interactions (FDA/EMA) and briefing packages.
• Monitor regulatory changes and ensure compliance with ICH and international guidelines.

Skills

Regulatory CMC

Biologics

Module 3

FDA/EMA knowledge

ICH guidelines

Job description

Ledgent Technology seeks a Senior Regulatory CMC Lead to drive global regulatory CMC strategy for biologic programs from Boston. The role leads MAA/BLA submissions with emphasis on Module 3, coordinating global teams and regulatory submissions.

The ideal candidate has a decade of regulatory affairs CMC experience in biotech/pharma, strong knowledge of FDA/EMA guidelines, and proven ability to manage complex regulatory strategies in a global matrix organization.