Kaye/Bassman International · 4 days ago
Vice President Regulatory CMC
Somerset County, NJ
Full-time
Hybrid
Director/Executive
15+ years expKaye/Bassman International is a global, clinical-stage biopharmaceutical organization developing innovative therapies for serious immunologic diseases. They are seeking a Vice President, Regulatory CMC to provide strategic leadership across global regulatory CMC activities, overseeing submissions and interactions with health authorities while building a high-performing regulatory organization.
ConsultingHuman Resources
Hiring Manager
Edward Canning
Responsibilities
Lead and execute global regulatory CMC strategy across development and lifecycle management
Serve as the primary regulatory CMC interface with FDA, EMA, and global health authorities
Provide executive oversight and hands-on leadership for INDs, BLAs, NDAs, MAAs, CTAs, and regulatory CMC briefing packages
Guide regulatory CMC strategy for biologics and drug-device combination products
Partner cross-functionally with Clinical, Regulatory, Quality, Manufacturing, and Commercial teams
Anticipate regulatory risk and provide proactive mitigation strategies
Ensure regulatory plans align with corporate objectives and timelines
Build, mentor, and scale the global Regulatory CMC organization
Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs
Monitor FDA and EMA CMC regulations and guidance to assess and manage relevant changes and implications to current and future development and commercial activities
Qualification
Required
15+ years of progressive Regulatory CMC experience, including senior leadership roles
Demonstrated success leading global Regulatory CMC strategies and major submissions
Extensive experience interfacing directly with global health authorities
Experience supporting early- and late-stage development programs
Extensive experience in biologics and combination products required
Proven ability to lead, mentor, and develop teams
Strong executive presence, strategic thinking, and communication skills
Experience in both biotechnology and pharmaceutical environments
Demonstrated ability to supervise Regulatory CMC staff and contract CMC Regulatory
Preferred
An advanced degree (MS, PhD, PharmD) is strongly preferred
US RAC certification is a plus
Company
Kaye/Bassman International
Kaye/Bassman International is a staffing and recruiting company that offers executive search and professional recruitment.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Jeff Kaye
Co-C.E.O.
Recent News
2024-11-16
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