Global Regulatory Director – Infectious Disease Vaccines

Scorpion Therapeutics; Frederick (MD); On-site; USD 180,000 - 320,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Director of Regulatory Affairs for Infectious Disease biologics and vaccines to provide strategic leadership from early development through initial registration.

You will shape global regulatory strategies, lead submissions (INDs, amendments, marketing applications), serve as the primary agency contact with the FDA and international authorities, and guide lifecycle management while collaborating cross-functionally with clinical, nonclinical, CMC, and

Qualifications

• 12+ years in regulatory affairs with global strategy experience.
• Experience leading vaccine or infectious disease biologics programs.
• Proven success from development to regulatory approval.
• Extensive experience with FDA and global agencies.

Responsibilities

• Develop and execute global regulatory strategies.
• Lead regulatory submissions (INDs, amendments, marketing applications).
• Serve as primary agency contact with FDA and other authorities.
• Oversee lifecycle management and cross-functional collaboration.

Skills

Regulatory leadership

Strategic planning

Cross-functional collaboration

Communication

Education

Bachelor's in biological or pharmaceutical sciences

Job description

Scorpion Therapeutics is seeking a Senior Director of Regulatory Affairs for Infectious Disease biologics and vaccines to provide strategic leadership from early development through initial registration.

You will shape global regulatory strategies, lead submissions (INDs, amendments, marketing applications), serve as the primary agency contact with the FDA and international authorities, and guide lifecycle management while collaborating cross-functionally with clinical, nonclinical, CMC, and