Sr. Director , Regulatory Affairs, Global Regulatory Lead - Development Strategy

Role Summary

Sr. Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy. Lead global regulatory strategies and plans to enable efficient product development for assigned programs; act as primary regulatory contact for U.S. FDA; accountable for regulatory submissions and communications with global Health Authorities.

Responsibilities

• Lead development and execution of global regulatory strategies for clinical, pre-clinical, and lifecycle management activities for assigned programs
• Identify and assess regulatory risks associated with product development and define risk-mitigation strategies
• Provide regulatory guidance across functions throughout the R&D process and advise on the US IND and global CTA submission strategies
• Direct the planning and coordination of global regulatory submissions, including clinical trial applications for multinational trials, core briefing packages, and global marketing applications
• Oversee the organization and preparation of clear, concise, and effective regulatory submissions
• Provide oversight for preparation and delivery of materials for regulatory agency meetings
• Prepare and deliver high-quality presentations for both internal and external audiences
• Monitor, evaluate, and interpret global regulatory agency activities in relevant areas; assess potential impact on company programs
• Lead effectively in a matrix environment, collaborating with regional regulatory leads and cross-functional teams

Qualifications

• Bachelor’s degree in life sciences or a related field required; advanced degree strongly preferred
• Minimum of 5 years of experience in Regulatory Affairs with hands-on experience in regulatory submissions across multiple regions
• Strong knowledge of global regulatory requirements and submission formats (eCTD)
• Proven experience managing complex regulatory deliverables across product lifecycle stages
• Strong submission writing and review skills
• Experience with orphan drug products strongly preferred
• Experience with inhalation products a plus
• Significant experience interacting with FDA, EMA, and other global regulatory agencies
• Deep understanding of the drug development process
• Highly organized with strong attention to detail, accuracy, clarity, and conciseness
• Ability to manage tight deadlines; efficient, detail-oriented, adaptable, and a self-starter