Vice President, Oncology Regulatory Strategy
Core
Define and execute global regulatory strategy for oncology portfolios to accelerate product approvals and access for patients.
Role type
VP, Oncology Regulatory Strategy & Science
Builds
Globally aligned regulatory pathways for small molecules and biologics
Domain
Life Sciences / Oncology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory strategy, portfolio leadership, people management, budget management ($10M+), stakeholder engagement, submission review, policy anticipation, external representation
Preferred skills
Small molecules and biologics leadership, regulatory policy shaping, innovative clinical development (master protocols, adaptive designs), companion diagnostics, digital tools in regulatory ops, global regulatory requirements (FDA, EMA, APAC, LATAM)
Technologies
Digital tools, automation, data analytics
Responsibilities
Set long-term oncology regulatory strategy, lead Centre of Excellence, partner with SVP on governance, define global strategies for assigned programs, advance digital/data in regulatory science, lead Executive Directors and Global Regulatory Leaders, influence business/portfolio decisions, manage in/out-licensing regulatory diligence, represent company at key forums (DIA, trade associations), review/approve submission documents, champion best practices, manage area budgets
Seniority
VP, Executive level