Senior Regulatory CMC Lead

Job Description

Job Description

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.

4 Cross-Functional Leadership

• Operate effectively in a global matrix environment.
• Coordinate cross-functional contributors and external partners where relevant.
• Facilitate alignment between technical, regulatory, and program objectives.
• Determine timelines and deliverables across multiple stakeholders.

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.
• Demonstrated experience defining and implementing global regulatory strategies.

Technical and Professional Competencies

• Strong strategic thinking and decision-making capabilities.
• Excellent critical thinking and problem-solving skills.
• Ability to prioritize multiple projects and competing timelines.
• Strong stakeholder management and communication skills.
• Experience working collaboratively in cross-functional and international teams.
• Pragmatic, scientifically driven, organized, and solution-oriented mindset.

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.