Head / Senior Director of Regulatory Affairs

Job Title: Head/Senior Director of Regulatory Affairs Job Number: 37251 Location: New York, NY Overview As Head of Regulatory Affairs, you will shape and lead the regulatory strategy for the company's oncology portfolio, overseeing programs from early development through late-stage trials and into U.S. and global approvals. You will act as the company’s main regulatory representative with the FDA and international health authorities, while establishing regulatory approaches that enable expedited pathways, orphan drug programs, and innovative clinical trial designs. This is a hybrid position. Responsibilities Design and implement global regulatory strategies for oncology programs spanning early through late development, from IND to BLA Anticipate regulatory challenges and proactively develop risk-mitigation plans aligned with development timelines and commercial goals Direct and manage all regulatory filings, including INDs, briefing packages, clinical protocols, BLAs, and applications for expedited pathways such as Fast Track, Breakthrough Therapy, Accelerated Approval, and Orphan Drug designation Serve as a senior regulatory lead in engagements with the FDA, EMA, and other international health authorities, including leading agency meetings and negotiations Ensure regulatory rigor across preclinical, clinical, and CMC activities by reviewing and approving regulatory documentation for accuracy, quality, and compliance Work closely with Clinical Development to embed regulatory considerations into development strategies, study designs, and endpoint selection Partner with Medical to provide regulatory oversight of pharmacovigilance processes, safety reporting, and related SOPs Collaborate with Manufacturing, Quality, and Product Development teams to define and execute CMC regulatory strategies, including assessment of change controls Track and communicate evolving regulatory requirements, scientific advances, policy changes, novel endpoints, and innovative trial approaches to senior leadership Present regulatory strategies, key risks, and recommendations to executive management Maintain compliance with ongoing regulatory commitments, including amendments, annual reports, safety submissions, and global filings Represent Regulatory Affairs on cross-functional teams, partnering with Clinical, CMC, Preclinical, Supply Chain, and Operations functions Promote continuous improvement through sound regulatory judgment, strategic thinking, and application of best practices Required Skills Advanced degree (MS, PhD, or MD) in life sciences or a related health discipline Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, including at least 10 years in Regulatory Affairs Background working in both large pharmaceutical companies and emerging or mid-sized biotech organizations Required subject matter expertise in solid tumor oncology, biologics, and targeted radiotherapy/radiopharmaceuticals Demonstrated leadership of IND, NDA, and BLA submissions from development through approval Prior experience with radioligand therapies and theranostics strongly preferred In-depth understanding of U.S. and international regulatory frameworks, including FDA biologics review processes and pre-approval inspection readiness Strategic thinker capable of translating complex scientific data into actionable regulatory strategies Experience supporting orphan indications and navigating expedited development and approval pathways Proven leadership, communication, and ability to influence across cross-functional teams Ability to work independently, manage priorities effectively, and deliver results in a fast-paced environment Documented success engaging directly with global regulatory agencies Results-driven, detail-oriented, and accountable leader with a hands-on, execution-focused approach Competitive compensation including base salary, performance bonus, equity, 401(k) with company match, and comprehensive benefits #J-18808-Ljbffr The University of Texas MD Anderson Cancer Center