Senior Director Regulatory Affairs
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
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
