Director, Regulatory CMC - Cell Therapy

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

Role:

The Director of Regulatory CMC for Cell Therapy oversees management of multiple development and lifecycle projects, representing GRS-CMC in cross-functional teams, governance, and regulatory engagements.

Responsibilities

Responsibilities include developing and communicating global regulatory strategies, preparing and reviewing CMC submissions, ensuring compliance, and supporting external regulatory interactions and health authority meetings. The role also involves leading and mentoring direct reports, monitoring regulatory guidelines, and contributing to policy development.

Requirements

BA/BS degree, at least 10 years of pharmaceutical experience with 8+ years in regulatory CMC, with knowledge of advanced therapies, biologics, and cell therapies during development and post-approval.

Key Competencies

Key competencies include expertise in CMC regulatory requirements, pharmaceutical development processes, cross-functional leadership, and global regulatory strategy development.

HighValue:

focus on cell therapy, advanced therapies, biologics, drug development stages from clinical to post-market, global regulatory compliance, and leadership in regulatory submissions and strategy.

Additional Information

The position may require up to 5% travel and is based on-site or hybrid.