Senior Director, Global Regulatory Strategy

ABA Search, Inc.; South San Francisco (CA); On-site; USD 270,000 - 280,000; Full time

Job summary

ABA Search, Inc. is seeking a Director of Regulatory Affairs in South San Francisco to shape worldwide regulatory strategy for novel programs. You will advise executive leadership and partner across clinical, CMC, and commercial teams in a startup-like environment.

The role offers responsibility for IND/CTA submissions, global health authority interactions, and strategic guidance from IND-enabling work through proof-of-concept and beyond. On-site presence is required at least four days per week.

Qualifications

• Master’s degree in a life science discipline.
• 10+ years of regulatory affairs experience.
• Direct experience authoring and managing regulatory submissions (INDs/CTAs).
• Strong knowledge of global regulations (FDA/EMA).
• Experience with mechanisms to expedite agency interactions.
• Excellent communication and ability to influence stakeholders.
• Willingness to work on-site at least four days per week.
• PhD is preferred.

Responsibilities

• Develop and execute worldwide regulatory strategy for assigned programs.
• Advise executive leadership and cross-functional teams on trial design and endpoints.
• Lead interactions with global health authorities and briefing packages.
• Oversee submission compilation and timeliness.
• Partner with CMC to align regulatory strategies.
• Represent Regulatory Affairs on development teams and interpret regulations.
• Monitor regulatory developments and brief senior leadership.

Skills

Regulatory strategy

FDA/EMA knowledge

Health authority interactions

Regulatory submissions

Communication

Cross-functional collaboration

Independent work

Education

Master's degree in life sciences

Job description

ABA Search, Inc. is seeking a Director of Regulatory Affairs in South San Francisco to shape worldwide regulatory strategy for novel programs. You will advise executive leadership and partner across clinical, CMC, and commercial teams in a startup-like environment.

The role offers responsibility for IND/CTA submissions, global health authority interactions, and strategic guidance from IND-enabling work through proof-of-concept and beyond. On-site presence is required at least four days per week.