Senior Director, Global Regulatory Affairs – Biotech Unit

Accountabilities:

• • 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.

  Requirements:

  • 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 regulatory approval actions.
  • Extensive experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, Health Authority interactions, and global regulatory strategy development.
  • Strong understanding of the drug development lifecycle, pharmaceutical industry, healthcare environment, regulatory requirements, and evolving policy trends.
  • Demonstrated ability to develop and execute regulatory strategies while balancing immediate program needs with longer-term objectives.
  • Experience managing complex regulatory risks, identifying strategic challenges, and developing creative, practical solutions.
  • Proven ability to lead and influence within highly cross-functional and partnership-oriented environments without direct reporting responsibility.
  • Excellent interpersonal and communication skills, with the ability to build trusted relationships and influence stakeholders at all organizational levels.
  • Strong analytical, strategic, decision-making, and problem-solving capabilities, combined with a results-oriented approach.
  • Ability to operate effectively in a global, fast-moving environment and collaborate across cultures, functions, geographies, and time zones.
  • Fluent written and spoken English; Mandarin language skills are desirable.
  • Strong proficiency with Microsoft Office Suite and common business productivity tools.
  • Willingness and ability to travel domestically and internationally, up to approximately 20%.

  Benefits:

  • Base salary: $211,200–$281,200 annually, with final compensation determined by skills, experience, education, certifications, and work location.
  • Eligibility for an annual bonus plan for non-commercial roles.
  • Opportunity to receive discretionary equity awards and participate voluntarily in an Employee Stock Purchase Plan.
  • Comprehensive medical, dental, and vision insurance.
  • 401(k) retirement plan.
  • FSA/HSA benefits.
  • Life insurance coverage.
  • Paid time off and wellness benefits.
  • Remote work opportunity within the United States.
  • Exposure to global oncology programs and cross-functional collaboration across international teams.
  • Opportunities to contribute to innovative development models and initiatives focused on improving access to cancer treatments.
  • An inclusive workplace committed to equal employment opportunity and professional collaboration.
  • Travel opportunities of up to 20%, including domestic and international engagement.