Regulatory CMC Director Cell Therapy Strategy Submissions

Scorpion Therapeutics; Bethesda (MD); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Director of Regulatory CMC for Cell Therapy to lead global regulatory strategy and submissions across development and lifecycle stages. The role focuses on cell therapy programs, with emphasis on advanced therapies and biologics, requiring collaboration with cross-functional teams at a global level.

On-site or hybrid work arrangements are available, with travel up to 5%, and a leadership role in regulatory submissions and strategy development.

Qualifications

• Bachelor’s degree or higher required.
• 10+ years of pharmaceutical experience with 8+ years in regulatory CMC.
• Experience with advanced therapies, biologics, and cell therapies.

Responsibilities

• Develop and communicate global regulatory strategies for CMC in cell therapy.
• Prepare and review CMC submissions.
• Ensure regulatory compliance across development and post-approval stages.
• Support external regulatory interactions and health authority meetings.
• Lead and mentor direct reports, monitor guidelines, and contribute to policy development.

Skills

CMC regulatory

Global regulatory strategy

Cross-functional leadership

Regulatory submissions

Education

BA/BS degree

Job description

Scorpion Therapeutics is seeking a Director of Regulatory CMC for Cell Therapy to lead global regulatory strategy and submissions across development and lifecycle stages. The role focuses on cell therapy programs, with emphasis on advanced therapies and biologics, requiring collaboration with cross-functional teams at a global level.

On-site or hybrid work arrangements are available, with travel up to 5%, and a leadership role in regulatory submissions and strategy development.