Senior Director, Regulatory Affairs

Position Summary:

The Senior 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:

• Bachelors degree advanced degree preferred in life sciences pharmacy chemistry or related field with 12 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