iO Associates is supporting a clinical-stage biotech with programs in Phase 2/3 and a multi-year runway in their search for an Executive Vice President, Regulatory Affairs. You will be the senior-most regulatory leader, reporting to the CMO and sitting on core program teams. You'll set the end-to-end regulatory roadmap and lead high-stakes interactions with global health authorities to secure and maintain market access.

Key responsibilities

Define and drive global regulatory strategy across development and pre-/post-approval phases.
Serve as primary interface with FDA and partner on EMA/other agencies; plan and lead key meetings.
Orchestrate high-quality submissions (IND/CTA → NDA/MAA, labeling, briefing packages) with Clinical, CMC, Safety, and Biometrics.
Build, mentor, and scale the Regulatory Affairs function; establish SOPs, policies, and best practices.
Anticipate/mitigate regulatory risks; shape positions on evolving guidelines and the competitive landscape.
Contribute to corporate planning, governance, and selective BD diligence.

Qualifications

20+ years in pharma/biotech; 15+ years leading Regulatory Affairs for small-molecule programs.
Proven record of US/EU submissions and approvals; confident leading FDA/EMA engagements.
Late-stage (Phase 3/pivotal) experience; eCTD/CTD fluency.
Strong cross-functional leadership with Clinical, CMC, Safety; able to build teams and systems in a lean environment.

Location & work style

California (hybrid) with periodic on-site time