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.