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.
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.
