Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

Senior Manager/Associate Director position leading regulatory strategy for hematology-oncology programs at a clinical-stage biotech company. Responsible for building and executing global regulatory strategies, managing product development applications, and ensuring compliance across investigational and marketing programs.

Responsibilities

• Develop and execute global regulatory strategies for assigned hematology-oncology programs
• Serve as regulatory representative on early and late-phase clinical studies to ensure compliance
• Prepare regulatory submissions including INDs, NDAs, DSURs, and investigator brochures
• Conduct meetings with regulatory authorities and respond to agency inquiries
• Track regulatory deliverables, manage submission timelines, and oversee quality assurance processes

Requirements

• Bachelor's degree in life sciences, chemistry, pharmacy, or related field
• 10+ years regulatory affairs experience in pharmaceutical development
• Demonstrated expertise in US and global regulatory requirements and authority interactions
• Proven experience managing INDs, CTAs, NDAs, and lifecycle regulatory submissions
• Strong knowledge of oncology drug development and hematology-oncology therapeutic area
• Experience leading cross-functional teams and managing regulatory consultants
• Proficiency with regulatory information management systems and submission planning tools