The Senior Global Regulatory Affairs Program Lead will serve as the end-to-end regulatory owner for a high-priority Biologics License Application (BLA) supporting, a monoclonal antibody therapy for spinal muscular atrophy. This individual will lead global regulatory strategy, execution, and stakeholder coordination from late-stage BLA preparation through approval and post-approval lifecycle expansion.
This is a top-tier regulatory leadership role requiring deep biologics expertise, strong Health Authority interaction experience, and the ability to run a complex, multi-vendor global program with minimal oversight. Continuity is critical; the selected consultant is expected to remain on the program for the full contract duration.
Key Responsibilities
Serve as the global regulatory lead, owning strategy, execution, and delivery for the BLA submission targeted for 2026. Lead and coordinate regulatory activities across client's sponsor, and external vendors and consultants. Develop and maintain the global regulatory strategy, submission roadmap, and detailed project timelines across the U.S., EU, and Japan. Oversee BLA submission activities, including preparation for potential FDA safety-related delays or regulatory contingencies. Act as the primary regulatory point of contact with the FDA and other global Health Authorities, including meeting preparation, correspondence, and response strategy. Identify the fastest, lowest-risk path to market, proactively addressing risks, delays, and execution challenges. Lead post-approval planning, including repurposing the BLA for injectable formulations and supporting global lifecycle management. Provide hands-on execution support while also mentoring and upskilling the sponsor team on regulatory processes and best practices. Build and scale the extended regulatory team as needed, including recommending and onboarding additional consultants or vendors. Take ownership of issue resolution, driving corrective actions to bring the program back on track when timelines or deliverables are at risk. Ensure alignment across regulatory, clinical, CMC, and quality functions throughout the program lifecycle. Required Qualifications
Bachelors degree in related field is required; advanced degree preferred. Extensive senior-level experience in global regulatory affairs, with demonstrated ownership of BLA strategy and execution. Proven experience leading biologics programs, particularly for complex or rare disease indications. Strong scientific background; experience with IDV4 monoclonal antibodies and lifecycle transitions (e.g., injectable formulations) highly preferred. Deep understanding of U.S. FDA regulatory pathways, with direct experience engaging Health Authorities. Working knowledge of EU and Japan regulatory frameworks for biologics. Demonstrated ability to lead large, cross-functional, multi-vendor programs from a top-down, strategic perspective. Exceptional project leadership skills, including risk management, timeline recovery, and decision-making under pressure. Comfortable operating as a trusted regulatory advisor to senior sponsor leadership. Ability to commit to a long-term engagement (18+ months) with continuity through approval and post-approval phases.
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Serve as the global regulatory lead, owning strategy, execution, and delivery for the BLA submission targeted for 2026. Lead and coordinate regulatory activities across client's sponsor, and external vendors and consultants. Develop and maintain the global regulatory strategy, submission roadmap, and detailed project timelines across the U.S., EU, and Japan. Oversee BLA submission activities, including preparation for potential FDA safety-related delays or regulatory contingencies. Act as the primary regulatory point of contact with the FDA and other global Health Authorities, including meeting preparation, correspondence, and response strategy. Identify the fastest, lowest-risk path to market, proactively addressing risks, delays, and execution challenges. Lead post-approval planning, including repurposing the BLA for injectable formulations and supporting global lifecycle management. Provide hands-on execution support while also mentoring and upskilling the sponsor team on regulatory processes and best practices. Build and scale the extended regulatory team as needed, including recommending and onboarding additional consultants or vendors. Take ownership of issue resolution, driving corrective actions to bring the program back on track when timelines or deliverables are at risk. Ensure alignment across regulatory, clinical, CMC, and quality functions throughout the program lifecycle. Required Qualifications
Bachelors degree in related field is required; advanced degree preferred. Extensive senior-level experience in global regulatory affairs, with demonstrated ownership of BLA strategy and execution. Proven experience leading biologics programs, particularly for complex or rare disease indications. Strong scientific background; experience with IDV4 monoclonal antibodies and lifecycle transitions (e.g., injectable formulations) highly preferred. Deep understanding of U.S. FDA regulatory pathways, with direct experience engaging Health Authorities. Working knowledge of EU and Japan regulatory frameworks for biologics. Demonstrated ability to lead large, cross-functional, multi-vendor programs from a top-down, strategic perspective. Exceptional project leadership skills, including risk management, timeline recovery, and decision-making under pressure. Comfortable operating as a trusted regulatory advisor to senior sponsor leadership. Ability to commit to a long-term engagement (18+ months) with continuity through approval and post-approval phases.
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