Senior Regulatory CMC Lead

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

I'm currently looking for a Senior Regulatory CMC Lead (Chemistry, Manufacturing, and Controls.) to support a high-impact global Antibody-Drug Conjugate (ADC) biologics program with a leading pharmaceutical organization.

This is a senior-level Regulatory CMC consulting opportunity focused on global regulatory strategy, MAA/BLA submissions, and cross-functional leadership.

Travel:

Up to 10% to Boston or Paris

What You'll Do

• Lead global Regulatory CMC strategy for a biologic ADC program.
• Provide strategic leadership for MAA and/or BLA preparation and submission.
• Lead the CMC aspects of global regulatory submissions.
• Review and support Module 3 preparation and finalization.
• Support responses to FDA, EMA, and other global health authority questions.
• Lead preparation for regulatory agency meetings and CMC discussions.
• Identify regulatory risks and develop mitigation strategies.
• Work closely with Regulatory Affairs, CMC, Quality, Manufacturing, NBE/NCE teams, technical writers, and external partners.
• Drive alignment across a complex global matrix organization.
• 10+ years of Regulatory Affairs CMC experience within biotech or pharmaceutical environments.
• Proven experience leading Module 3 for biologic MAA and/or BLA submissions.
• Strong biologics regulatory CMC expertise.
• Experience with FDA, EMA, and ICH regulatory requirements.
• Demonstrated experience developing and implementing global regulatory strategies.
• Strong cross-functional and stakeholder management skills.
• Ability to manage multiple priorities, timelines, and global contributors.
• Strategic, scientifically driven, pragmatic, and solution-oriented approach.

Why This Opportunity?

You’ll have the opportunity to play a key role in the global registration strategy for an innovative ADC biologic program, working across regulatory, technical, manufacturing, quality, and development teams.

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