Senior Director, Regulatory Affairs

CytomX Therapeutics, Inc.; Emeryville (CA); Hybrid; USD 250,000 - 285,000; Full time

Job summary

CytomX Therapeutics, Inc. in Emeryville, CA is seeking an experienced regulatory affairs leader to drive global strategy for late-stage programs, lead major filings, and represent the company in regulatory meetings.

Reporting to the SVP, Regulatory Affairs, you will partner with cross-functional teams to align plans, manage risk, and ensure submission readiness across US and EU.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• 10 years minimum of significant progressive regulatory affairs experience in biotechnology or pharmaceuticals, including global late-stage development and registration strategy.
• Experience leading major regulatory filings or marketing-application activities.
• Substantial experience preparing for and participating in regulatory agency meetings.

Responsibilities

• Lead integrated global regulatory strategies for late-stage programs, with primary US/EU responsibility.
• 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, and follow-up.
• Guide regulatory pathways, health-authority interactions, registration planning, and submission activities.
• Serve as senior regulatory representative on cross-functional teams and advise leadership on regulatory risks and opportunities.
• Provide regulatory input to clinical development plans, pivotal study design, labeling, and evidence-generation plans.
• Ensure regulatory positions are consistent across regions and governance forums.
• Build relationships with health authorities, partners, consultants, and internal stakeholders; mentor colleagues.

Skills

Regulatory leadership

Global regulatory strategy

FDA meetings

Regulatory filings

Cross-functional collaboration

Project management

Education

Bachelor’s degree in science/related field

Advanced degree (Pharm D/Ph.D./MD preferred)

Job description

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 atwww.cytomX.com.

Location and Reporting

• Headquarters Location: Emeryville, CA
• Candidate Location: Hybrid
• Travel Required: 20%
• Reports To: SVP, Regulatory Affairs
• Department: Regulatory Affairs
• Position Type: Full-time, Exempt

Who You Are and What You’ll Do

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.

Job 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.

Minimum 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)
• 10 years minimum of significant progressive regulatory affairs experience in biotechnology or pharmaceuticals, including global late-stage development and registration strategy.
• Demonstrated regulatory leadership, including health-authority interactions and registration planning or execution.
• Experience leading major regulatory filings or marketing-application activities.
• 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.

Preferred Qualifications

• Oncology and/or biologics regulatory experience.
• Regulatory development, health-authority interaction, filing experience in China and/or Japan.
• Experience with expedited pathways, external partnerships, and a small to mid-sized biotechnology environment.

How You Will Work

• 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.
• Demonstrates a patient focus. Puts the patient first in actions and decisions taken.
• Contributes to strategy and innovation. Contributes to or leads elevating and actionable strategies. Ideates and creates unique opportunities to advance the organization.
• Demonstrates leadership and a commitment to organizational values. Takes ownership and has a strong sense of personal accountability. Consistently achieves or exceeds goals and expectations. Puts significant emphasis on living / upholding company values.

Compensation, Benefits, And So Much More

• The expected salary range for this role based on the primary location for this position in California is $250,000 - $285,000 per year. Offer amounts are determined by factors such as experience, qualifications, geographic location, and other job-related factors permitted by law.
• A great environment where we work collaboratively, leverage each other’s strengths, and work toward a shared vision with our common goals of doing the best thing for patients.
• A robust and enduring approach to your development and career growth fueled by a strong learning curriculum and career guidance that helps you understand how you can grow your career at CytomX.
• A robust and highly competitive total rewards program that helps you achieve your compensation goals while supporting a great work / life balance.

Conditions of Employment

• Background investigations are required for all positions at CytomX, consistent with applicable law.

CytomX’s Commitment to Diversity, Equity, Inclusion, and Belonging (DEIB)

CytomX believes that DEIB helps drive our success, and we encourage candidates from all identities, backgrounds, and abilities to apply. We are an equal opportunity employer committed to building an inclusive, innovative work environment with employees who reflect our values and ultimately, serve our patients. Therefore, in all aspects of the employment process, we provide employment opportunities to all qualified applicants without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity or expression, pregnancy, medical condition related to pregnancy, creed, ancestry, national origin, marital status, genetic information, or military status, or any other protected status in accordance with applicable law.