Senior Regulatory CMC Lead - Biologic ADC Global Strategy

Meet Life Sciences Ltd.; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Meet Life Sciences Ltd. seeks a Senior Regulatory CMC Lead to drive global regulatory strategy for an ADC biologics program.

You will lead Module 3 activities and provide strategic direction for MAA/BLA submissions, coordinating with Regulatory Affairs, CMC, Quality and Manufacturing teams across regions. The role requires 10+ years in Regulatory Affairs CMC within biotech/pharma, with deep expertise in FDA/EMA requirements and cross-functional leadership to manage multi-country submissions and

Qualifications

• At least 10+ years in Regulatory Affairs CMC in biotech/pharma settings.
• Experience leading Module 3 for biologic MAA/BLA submissions.
• Strong working knowledge of FDA, EMA and ICH guidelines.

Responsibilities

• Lead global Regulatory CMC strategy for biologic ADC programs.
• Provide leadership for MAA/BLA preparation and submissions.
• Oversee CMC aspects of global regulatory submissions and responses.

Skills

Regulatory CMC strategy

Module 3

Biologics regulatory CMC

FDA/EMA/ICH

Cross-functional leadership

Global regulatory strategy

Stakeholder management

Project management

Regulatory submissions

Biotech/pharma expertise

Job description

Meet Life Sciences Ltd. seeks a Senior Regulatory CMC Lead to drive global regulatory strategy for an ADC biologics program.

You will lead Module 3 activities and provide strategic direction for MAA/BLA submissions, coordinating with Regulatory Affairs, CMC, Quality and Manufacturing teams across regions. The role requires 10+ years in Regulatory Affairs CMC within biotech/pharma, with deep expertise in FDA/EMA requirements and cross-functional leadership to manage multi-country submissions and