Executive Vice President of Regulatory Affairs

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