Senior Director Regulatory Affairs

Job Summary

A company is looking for a Sr. Director RA Early Development Lead.

Key Responsibilities

• Own global regulatory strategy for early-stage programs, from pre-IND through proof of concept
• Lead a cross-functional regulatory team dedicated to early clinical development
• Engage with global health authorities and regulatory forums to represent the organization externally

Required Qualifications, Training, and Education

• 15+ years in regulatory affairs within global biotech/pharma, including senior leadership roles
• Significant expertise in early-stage development with hands-on experience in designing global regulatory strategies for FIH programs
• Deep scientific fluency; PhD or PharmD preferred
• Track record in advancing biologics or innovative therapies into the clinic
• Collaborative and experienced in scaling regulatory operations