Vice President, Global Regulatory Affairs

Role Summary

Vice President, Global Regulatory Affairs responsible for strategic and operational leadership of regulatory functions to achieve business objectives and ensure compliance with government regulations, industry guidelines, and best practices. Leads planning of regulatory milestones and preparation, review, and evaluation of documents for submission to regulatory authorities (e.g., INDs and BLAs).

Responsibilities

• Provide executive leadership and management in creating and executing global regulatory strategies for product development, approval and registration, novel clinical trial designs, and support of future marketed products.
• Develop and maintain regulatory knowledge of US, EU, and global regulations.
• Manage activities pertaining to interactions with FDA, EMA, and other global Health Authorities and communicate outcomes to the CMO-LT and Executive Leadership Team.
• Act as the primary regulatory representative on the CMO-LT and provide strategic regulatory guidance to project teams.
• Lead the planning and preparation of global regulatory submissions (e.g., INDs, CTAs, Orphan Drug Applications, IND safety reports, meeting requests, and anticipated BLA submissions) with ADCT partners as applicable.
• Prepare meeting requests and briefing documents; ensure team is ready for meetings/teleconferences with regulatory agencies.
• Serve as liaison between the company and regulatory authorities for assigned projects.
• Lead the Global Regulatory Affairs organization by recruiting, retaining, and developing staff.
• Establish and manage all regulatory timelines with the Global Project Manager.
• Ensure Global Regulatory Affairs meets corporate goals and remains compliant with global policies and regulations.
• Manage and collaborate with CRO partners for regulatory submissions and related activities.
• Support business development and due diligence with technical regulatory input.
• Champion adoption of emerging technologies and regulatory science initiatives to enhance efficiency and decision making.
• Oversee post-approval commitments and monitoring.
• Lead product labeling and promotional material committees to ensure content and compliance with global regulations.

Qualifications

• MD, PhD, or PharmD preferred, with 15+ years in regulatory affairs.
• Strong knowledge of regulatory affairs and FDA regulations; familiarity with EU and other international regulatory frameworks (e.g., Japan, China).
• Proven track record of successful interactions with US, EU, and other global regulatory agencies, including timely submissions and approvals.
• Experience in oncology and/or hematology preferred.
• Experience with biologics/pharmaceuticals desirable.
• Excellent verbal and written communication skills.
• Strong experience in managing and developing people.
• Ability to work in an agile, small-company environment, optimize resource allocation, and be hands-on in day-to-day work.
• Ability to collaborate across boundaries with global functions including ADCT partners.
• Strong leadership in presenting Regulatory Affairs positions to the Executive Leadership Team.