Senior Regulatory CMC Lead - 608817

Role Summary

Servier RegCMC 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.

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.

Requirements

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