Senior Director, Global Regulatory Affairs – Biotech Unit

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Global Regulatory Affairs – Biotech Unit based in United States.

This is a senior individual contributor role shaping global regulatory strategy for innovative oncology development programs and external biotech partnerships.
You will provide strategic and operational regulatory leadership across assets from early development through approval and lifecycle management.
The role spans major global markets, including the US, China, and Europe, and requires deep expertise in FDA and international regulatory frameworks.
You’ll work at the intersection of regulatory strategy, clinical development, scientific innovation, and business priorities.
As a key advisor to cross‑functional and partnership teams, you’ll help resolve complex regulatory challenges and accelerate development timelines.
The environment is highly collaborative, global, and entrepreneurial, with significant opportunity to influence new partnership models and development approaches.
This position offers the chance to contribute directly to programs designed to expand access to impactful oncology treatments worldwide.

• Develop, implement, and advise on global regulatory strategies for assigned oncology development programs, ensuring alignment with partnership objectives and overall development plans.
• Provide strategic and operational regulatory direction across the full product lifecycle, from early clinical development through marketing authorization, post‑approval activities, and lifecycle management.
• Apply deep knowledge of US, China, EU, and ICH regulatory requirements to guide development programs and regulatory decision‑making across multiple regions.
• Lead regulatory strategy development, risk assessments, critical issue management, and preparation for interactions with global Health Authorities.
• Oversee preparation and submission of regulatory documentation for investigational and marketing applications, ensuring quality, compliance, and adherence to established timelines.
• Review and provide regulatory input on INDs, CTAs, NDAs, BLAs, MAAs, NDSs, amendments, and other global submission materials.
• Lead and support interactions and negotiations with regulatory authorities, including resolution of complex regulatory issues and activities intended to facilitate timely approvals.
• Monitor changes in the global regulatory environment and assess their potential impact on development programs, business priorities, and regulatory strategies.
• Provide regulatory leadership to execution teams, supporting effective planning and high‑quality delivery of associated clinical studies.
• Conduct regular program and study reviews to provide mentorship, identify risks, monitor operational and quality KPIs, and ensure progress against timelines.
• Partner with advisory and execution functions to incorporate relevant scientific, operational, and regulatory perspectives into program strategy and execution.
• Contribute to the development, interpretation, standardization, and implementation of global regulatory processes and practices.
• Act as a strategic regulatory advisor within cross‑functional partnership teams, integrating functional expertise with business considerations to resolve complex challenges.
• Champion a global mindset, consistency, collaboration, and knowledge sharing across regulatory affairs activities.
• Provide leadership on critical regulatory issues and support organizational standards, policies, and strategic initiatives as required.

• Bachelor’s degree in a relevant discipline such as life sciences, pharmacy, medicine, or a related field; an advanced degree is preferred.
• At least 12 years of experience in the biotechnology or pharmaceutical industry
  , including 5+ years in a regulatory leadership capacity
  .
• Broad and substantial experience in oncology regulatory affairs and drug development.
• Demonstrated experience leading Regulatory Affairs activities across at least two major geographic regions.
• Proven track record of leading multiple FDA interactions for oncology products resulting in…