Vice President Regulatory Affairs, Oncology (Drug)

Principal Duties and Responsibilities

• Develop and implement global regulatory strategies for drug development programs across preclinical development, clinical development and potential registration.
• Lead regulatory planning from IND enabling activities through clinical development and potential BLA submission.
• Advise executive leadership and the Board on regulatory risks, timelines, and strategic regulatory pathways.
• Serve as the primary regulatory voice in portfolio prioritization and development strategy, and regulatory governance discussions.
• Establish regulatory risk mitigation plans aligned with corporate objectives and development milestones.
• Lead preparation for and participation in meetings with regulatory agencies including FDA and other global health authorities (e.g., pre-IND, IND, scientific advice, end-of-phase meetings).
• Oversee preparation and submission of regulatory filings including INDs/CTAs, amendments, briefing packages, orphan applications, expedited designations and other regulatory submissions as programs advance.
• Serve as the primary contact with US and global regulatory authorities for drug related regulatory submissions.
• Drive strategies for expedited programs (e.g., Fast Track, Breakthrough Therapy, PRIME, etc., as applicable) in support of accelerated development pathways.
• Partner closely with Clinical, CMC, Nonclinical, Quality, and Commercial teams to ensure regulatory strategy is aligned with product development plans.
• Provide regulatory guidance on clinical development strategy, study design, endpoints, and labeling implications.
• Ensure regulatory requirements are integrated into CMC development plans and manufacturing strategies for future registration.
• Support due diligence activities, investor communications, and partnering discussions.
• Build scalable regulatory systems, processes, and document standards.
• Ensure timely, high-quality, compliant submissions.
• Oversee regulatory documentation lifecycle management.
• Recruit, mentor, and develop internal regulatory talent as the organization grows.
• Manage external consultants and CRO partners.
• Foster a collaborative, accountable, and mission-driven regulatory culture.
• Build infrastructure appropriate for growth from early development to later-stage operations and evolving regulatory requirements

Qualification Requirements

• Education: Masters degree required, advanced degree preferred.
• Experience: 15 years of regulatory affairs experience in biotechnology and/or pharmaceuticals. Experience supporting regulatory strategy for biologics and complex therapeutic platforms preferred. Direct experience leading interactions with FDA and international regulatory authorities. Experience preparing and leading major regulatory submissions including BLA.
• Skills: Strong understanding of CMC, nonclinical, and clinical regulatory requirements supporting biologics or complex therapeutics programs. Experience in oncology, biologics, cell/gene therapy, or other relevant modality. Experience in a small or emerging biotech company environment. Global regulatory experience including FDA and EMA, other regions a plus. Demonstrated ability to influence regulatory strategy and decision-making across multidisciplinary development teams. Strong communication, negotiation, and relationship-building skills; ability to communicate complex regulatory strategy to scientific and executive audiences. Excellent interpersonal communication skills; a highly communicative leader who maintains transparency both internally and externally. High level of integrity and professionalism with the ability to operate effectively in a fast-moving, early-stage biotechnology environment.

Work Environment

• Primarily sit
• Frequent standing and walking
• Lifting up to 20 pounds
• Repetitive motions
• Travel up to 50% regionally, some international

Company Information

• Equal Opportunity Employer
• Estimated US Salary Range: $345K-$375K
• This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.