Hiring: Senior Director, Regulatory Affairs Company: CytomX Therapeutics Location: Emeryville, CA Job Posted Time: 2026-09-16 21:33:51 Employment Type: Full-time / Hybrid About the job Experience: •10 years minimum of significant progressive regulatory affairs experience in biotechnology or pharmaceuticals, including global late-stage development and registration strategy. Required Skills: •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. Qualifications: •Bachelor’s degree in a scientific discipline such as biology, medicine or pharmacy or related, or equivalent relevant education and experience. Advanced degree (Pharm D, Ph.D., MD preferred) •Demonstrated regulatory leadership, including health-authority interactions and registration planning or execution. •Substantial experience preparing for and participating in regulatory agency meetings. •Strong knowledge of global drug-development requirements and the ability to lead complex cross-functional work and advise senior stakeholders. •Oncology and/or biologics regulatory experience. •Regulatory development, health-authority interaction, filing experience in China and/or Japan. •Demonstrates collaboration and teamwork. Works well with others and understands that collaboration leads to better results. •Possesses strong communication skills. Communicates clearly, concisely, and professionally. Listens actively to build understanding. •Exhibits strong interpersonal skills and self-awareness. Builds and cultivates strong and enduring relationships with others. Acts with humility and understands own strengths and weaknesses. •Shows continuous improvement and a commitment to self-management and development. Operates with a continuous improvement mindset and continuously seeks to expand own knowledge and capabilities. Compensation: •$250,000 - $285,000 / year •CytomX’s Commitment to Diversity, Equity, Inclusion, and Belonging (DEIB) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!