Senior Director, Regulatory Affairs
About CytomX Therapeutics
CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel PROBODY® therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes, and holding each other to the highest possible standards. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engagers, and immune modulators such as cytokines. CytomX’s clinical-stage pipeline includes CX-2051 and CX-801. Learn more at www.cytomx.com.
About the role
You are an experienced regulatory affairs leader with deep global early and late-stage development expertise and a strong track record in the US and European Union. Reporting to the SVP, Regulatory Affairs, you will lead global regulatory strategy for assigned programs, drive major filings, and represent CytomX in meetings with the regulatory authorities. You will partner across functions to establish clear regulatory plans, address risks, and support submission readiness and potential approvals.
Responsibilities
- Lead integrated global regulatory strategies for late-stage programs, with particular responsibility for the United States and European Union.
- Drive major regulatory filings, including strategy, planning, content, cross-functional coordination, and responses to health-authority questions.
- Lead FDA meeting strategy and preparation, including briefing materials, key questions, rehearsals, meeting participation, and follow-up.
- Guide regulatory pathways, health-authority interactions, registration planning, and submission activities.
- Serve as the senior regulatory representative on cross-functional teams and advise leadership on regulatory risks, opportunities, and decisions.
- Provide regulatory input to clinical development plans, pivotal study design, benefit-risk positioning, labeling, and evidence-generation plans.
- Ensure regulatory positions and commitments are consistent across regions, submissions, and internal governance forums.
- Build effective relationships with health authorities, partners, consultants, and internal stakeholders; mentor colleagues and improve regulatory practices.