Executive Director, Regulatory Affairs

Position Summary

The Executive Director of Regulatory Affairs is a senior leader responsible for developing and executing global regulatory strategy across the product portfolio. This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring full compliance with applicable regulations and guidance.

Responsibilities

• Develop and own global regulatory strategies for pipeline and marketed products, from early development through post-approval lifecycle management
• Serve as the primary regulatory strategist on cross-functional development teams (CDTs), aligning regulatory planning with clinical and commercial objectives
• Provide regulatory intelligence and proactive risk assessment to senior leadership, including Board-level briefings when appropriate
• Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements
• Partner with Clinical Development to provide input in designing early stage and registration-enabling trials, advising on endpoints, patient populations, statistical analysis plans, and labeling implications
• Review and provide regulatory input on protocols, IBs, CSRs, and other clinical documents to ensure alignment with regulatory strategy
• Lead preparation and execution of IND/CTA submissions and amendments; oversee clinical hold response strategy
• Drive BLA/NDA/MAA submission planning and execution, including authoring and reviewing Module 2 summaries and managing cross-functional submission teams
• Oversee preparation, review, and submission of major regulatory filings (IND, BLA/NDA, MAA) and post-approval submissions (CBEs, PASs, supplements, annual reports)
• Establish and maintain submission timelines, resource plans, and submission-readiness frameworks
• Ensure eCTD compliance and maintain submission infrastructure in partnership with Regulatory Operations
• Build, mentor, and retain a high-performing regulatory affairs team
• Monitor and interpret new and evolving FDA/EMA guidances, PDUFA commitments, and international regulatory developments; assess impact on programs and communicate to leadership

Qualifications

• Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, chemistry, or related field with 12-15 years of regulatory affairs experience in the pharmaceutical, biotechnology or medical device industry, or equivalent experience
• Demonstrated success leading BLA, NDA, or MAA submissions from initiation through approval
• Deep expertise in FDA regulations and guidance (21 CFR, ICH guidelines), with strong working knowledge of EMA and other major regulatory frameworks
• Proven track record of leading Health Authority meetings and managing complex, high-stakes regulatory interactions
• Experience in clinical regulatory strategy, including protocol design input, trial design, and endpoint negotiation with agencies
• Strong leadership skills with experience managing and developing teams of regulatory professionals
• RAC certification (RAPS) is a plus
• Experience across multiple therapeutic areas or modalities (small molecule, biologics, gene therapy, combination products) desirable
• Global regulatory experience including ex-US submissions and agency interactions desirable
• Prior experience with Breakthrough Therapy, Fast Track, Accelerated Approval, or other expedited designation programs preferred