Director, Regulatory Affairs

The Director, Regulatory Affairs will join a group of highly motivated regulatory professionals and play a critical role in shaping cohesive regulatory strategies across Deciphera’s product pipeline.The Director will operate as a strategic regulatory lead, developing and implementing global regulatory strategies for oncology programs from early development through post-marketing. This role will provide expert guidance to cross-functional teams, drive regulatory submissions, and ensure compliance with applicable regulations and industry standards.Key ResponsibilitiesRegulatory Strategy & LeadershipRegulatory lead for assigned oncology programs, developing and implementing innovative regulatory strategies from FIH through post-marketing stages.Provide regulatory input to clinical and development teams to ensure strategic alignment across functions.Monitor and interpret global regulatory trends and communicate potential impact on programs to senior leadership.Regulatory Submissions & ComplianceLead the preparation and submission of INDs, NDAs, and other regulatory filings in collaboration with cross-functional teams.Ensure all submissions are of high quality, compliant, and meet global regulatory expectations.Provide hands-on operational oversight for submission preparation, review, and delivery.Cross-Functional CollaborationPartner with Clinical Development, Clinical Operations, Quality, and CMC teams to ensure regulatory strategy integration across all development activities.Provide timely and accurate regulatory advice to project teams and senior management.Represent Regulatory Affairs at internal and external meetings, including interactions with regulatory authorities.Leadership & People ManagementProvide guidance and mentorship to Regulatory Affairs staff to enhance departmental capabilities.Assess team resources and project priorities to ensure timely delivery of key milestones.Promote a collaborative, solutions-oriented culture within the Regulatory Affairs organization.Process Improvement & InnovationContribute to continuous improvement initiatives and implement new processes to increase regulatory efficiency.Leverage learnings from prior projects to optimize global regulatory submissions and strategies.Foster innovation and strategic thinking in regulatory planning and execution.Other duties and responsibilities as assigned