Executive Director Global Regulatory Affairs

Title: Executive Director Global Regulatory Affairs

A leading global biopharmaceutical organization is seeking a seasoned Executive Director of Global Regulatory Strategy to lead regulatory initiatives across a diverse portfolio of innovative therapies. This is a high-impact, hands-on leadership role ideal for a strategic thinker with deep regulatory expertise and a passion for advancing global health.

Responsibilities:

• Provide strategic regulatory leadership for global development programs and marketed products across designated therapeutic areas.
• Lead and mentor a team of regulatory professionals in the development and execution of global regulatory strategies.
• Serve as the senior regulatory representative on cross-functional project teams throughout the product lifecycle.
• Advise executive leadership on U.S. and international regulatory matters, ensuring alignment with evolving global standards.
• Oversee planning and execution of regulatory agency interactions, including meetings with major health authorities (e.g., FDA, EMA, PMDA).

• Actively participate in Health Authority GCP inspections (e.g., FDA, EMA, PMDA) including responding to observations and development of corrective actions.

• Support regulatory inspections and audits, including response development and implementation of corrective actions.
• Monitor and interpret global regulatory trends, providing strategic insights and direction on emergency policy & regulatory intelligence.
• Drive continuous improvement in regulatory processes and team performance.
• Manage timelines, budgets, and resource planning for regulatory programs.
• Contribute to global regulatory policy initiatives and cross-functional governance committees.

Qualifications

• Bachelor's degree in a scientific discipline required; advanced degree (MS, PharmD, PhD, or equivalent) preferred.
• Minimum of 12 years of industry experience, including at least 10 years in regulatory affairs within the biopharma sector.
• Proven leadership experience managing regulatory teams and complex global submissions.
• Demonstrated success in leading regulatory strategy for major marketing applications (e.g., NDA, BLA, MAA).
• Strong track record of engagement with global regulatory agencies (FDA, EMA) and successful negotiation of regulatory pathways.
• Experience in managing the preparation of a marketing application (NDA/BLA/MAA) in CTD format for a major market (US, EU, Canada).
• Strategic mindset with the ability to navigate ambiguity and make informed decisions.
• Excellent communication and presentation skills, with the ability to influence at all levels of the organization.