Senior Regulatory CMC Lead

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

Senior Regulatory CMC Lead (JN -092026-431455) Boston, Massachusetts

Salary: USD100 - USD170 per hour

Schedule: Hybrid, open to remote

Pay: $100 - $170 per hour

Job Title: Senior Regulatory CMC Lead

Role Summary

Our Client is looking for a senior regulatory consultant to provide strategic and operational Regulatory CMC leadership support for a global Antibody-Drug Conjugate (ADC) biologics program. The selected consultant will play a critical role in leading global Regulatory CMC activities associated with Marketing Authorisation Applications (MAA) and/or Biologics License Applications (BLA), with a focus on global regulatory CMC strategy and matrix-management leadership.

The program involves a biologic ADC product intended for global registration, requiring senior-level expertise in Regulatory CMC strategy and execution across major health authorities, including EMA and FDA. The consultant will operate within a global matrix organization and will collaborate with multiple internal and external stakeholders across RegCMC (NBE, NCE and Technical writers’ teams), Regulatory Affairs, CMC, Quality, Manufacturing and Industry.

Primary Responsibilities

1. Global Regulatory CMC Strategy

• Lead and drive the global Regulatory CMC strategy for biologic ADC programs.
• Provide strategic guidance for global MAA/BLA preparation and submission activities.
• Ensure alignment of CMC regulatory strategies with overall development and commercialization objectives.
• Anticipate regulatory risks and propose mitigation strategies.

2 Regulatory Submission Leadership

• Lead the CMC aspects of global MAA and/or BLA.
• Review and support preparation / finalization of Module 3.
• Ensure consistency, scientific robustness, and regulatory compliance of submission content.
• Support responses to health authority questions and deficiency letters.

3 Health Authority Interaction Support

• Lead preparation for FDA, EMA, and other global agency interactions on CMC topics.
• Review briefing package development and meeting preparation.
• Provide strategic input on regulatory positioning and negotiation approaches.

3.5 Regulatory Intelligence and Compliance

• Maintain awareness of applicable ICH, FDA, EMA, and international regulatory guidelines related to biologics and ADC products.
• Ensure compliance with global regulatory expectations for Module 3.

Education and Required Skills

Mandatory Experience

• Minimum 10 years of experience in Regulatory Affairs CMC within the biotechnology and/or pharmaceutical industry.
• Proven hands-on experience leading Module 3 of biologic MAA and/or BLA submissions.
• Strong expertise in biologics.
• Understanding of ICH, FDA, and EMA regulatory requirements applicable to Module 3.

Travel and Location

• Max 10% to Boston office or Headquarters in Paris (France)
• Flexible for this to be Boston-office based, remote East-coast (USA) or hybrid.