Senior Director, Regulatory Affairs – Infectious Disease

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

Role

Senior Director of Regulatory Affairs for Infectious Disease biologics and vaccines, providing strategic leadership from early development through initial registration.

Responsibilities

• develop and execute global regulatory strategies
• lead regulatory submissions (INDs, amendments, marketing applications)
• serve as primary agency contact
• lead regulatory interactions with FDA and other authorities
• oversee lifecycle management
• and collaborate cross-functionally across clinical, nonclinical, CMC, and commercial teams.

Requirements

• Bachelor's in biological or pharmaceutical sciences
• 12+ years in regulatory affairs with experience leading global strategies for vaccine or infectious disease biologics
• proven success in guiding programs from early development to regulatory approval
• extensive experience with FDA and global regulatory agencies
• strong leadership and communication skills
• ability to manage multiple initiatives in a fast-paced environment

HighValue

• biologics
• infectious disease
• vaccines
• prophylactic or therapeutic biologics
• Phase 2 development
• global regulatory strategy
• FDA interactions
• lifecycle management
• cross-disciplinary leadership

WorkSetup

not specified, travel up to 20%.