DescriptionHeadquarters Location: Emeryville, CA
Candidate Location: Hybrid
Travel Required: 20%
Reports To: SVP, Regulatory Affairs
Department: Regulatory Affairs
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.
