Executive Director, Clinical Regulatory at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Executive Director, Clinical Regulatory in United States.

This role provides strategic leadership for global clinical regulatory activities, ensuring successful regulatory submissions and approvals for novel vaccines targeting both adult and pediatric populations. The Executive Director will develop and implement regulatory strategies, guide cross-functional teams, and liaise with global health authorities to facilitate clinical trial execution and commercialization. This position requires balancing technical expertise with strategic vision, providing regulatory guidance on complex issues, and driving compliance across multiple markets. You will influence regulatory decision-making, mitigate risks, and support the development of clinical programs while fostering collaboration among internal teams and external partners. The role operates remotely within the United States and requires high-level engagement with both senior leadership and regulatory agencies.

• Develop and execute globally aligned clinical regulatory strategies for investigational and commercial vaccines
• Author, review, and submit regulatory documents, including IND/IMPD, BLA/MAA, and post-approval notifications
• Provide guidance to cross-functional teams on regulatory requirements and clinical protocol development
• Serve as primary liaison with global regulatory authorities, including FDA, EMA, MHRA, PMDA, and Health Canada
• Lead negotiations and provide regulatory input to optimize timelines for clinical studies and commercial approvals
• Ensure adherence to global regulatory standards and maintain up-to-date knowledge of regulatory intelligence and legislation
• Manage regulatory compliance within multi-disciplinary teams, supporting operational excellence and decision-making

Requirements:

• BA or BS in clinical pharmacology, immunology, biology, medicine, bioanalytics, or related life sciences; advanced degrees or certifications a plus
• 15+ years of industry experience demonstrating technical and regulatory expertise in vaccine development
• 10+ years of relevant regulatory experience, with proven success in preparing and obtaining global regulatory approvals
• Strong understanding of clinical development, statistics, and regulatory pathways for vaccines
• Experience engaging with multiple health authorities and preparing investigational and commercial submissions
• Proven ability to lead cross-functional teams, identify regulatory risks, and develop mitigation strategies
• Excellent communication, strategic thinking, adaptability, and problem-solving skills
• Experience with global labeling, post-approval changes, and clinical program optimization

Benefits:

• Competitive base salary ($299,000–$349,000, SF Bay Area; varies by location)
• Comprehensive healthcare coverage, including medical, dental, and vision
• Equity component and retirement benefits
• Remote work flexibility within the United States
• Professional development opportunities and leadership exposure
• Supportive and collaborative work environment guided by core values of innovation, excellence, and inclusivity