Job Title
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.