Director, Gene Therapy CMC & Post-Approval Strategy

Scorpion Therapeutics; Boston (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Director of Regulatory CMC to lead global lifecycle and change management strategies for approved and late-stage gene therapy products. Hybrid work setup in Somerville, MA with cross-functional oversight spanning regulatory, manufacturing, quality, and program teams.

The candidate will drive post-approval submissions, manage change strategies, and ensure compliance with FDA/EMA/ICH guidelines, mentoring junior staff and coordinating with authorities as needed.

Qualifications

• 10-12+ years in biopharmaceutical CMC regulatory affairs, especially biologics or gene therapies.
• Experience with post-approval submissions and global regulatory frameworks (FDA, EMA, ICH).
• Strong written and verbal communication and cross-functional collaboration skills.

Responsibilities

• Oversee post-approval CMC activities including submissions of supplements and reports.
• Develop and implement change management strategies for lifecycle maintenance.
• Support manufacturing, supply continuity, inspection readiness, and regulatory interactions with authorities.
• Author and review CMC documentation and ensure adherence to global standards.
• Monitor emerging guidance and inspection trends; mentor junior team members.
• Collaborate with Tech Ops, Quality, Supply Chain, and Program teams.

Skills

Cross-functional collaboration

Regulatory affairs

Communication skills

Organizational skills

Education

Bachelor’s or Master’s in life sciences

Job description

Scorpion Therapeutics seeks a Director of Regulatory CMC to lead global lifecycle and change management strategies for approved and late-stage gene therapy products. Hybrid work setup in Somerville, MA with cross-functional oversight spanning regulatory, manufacturing, quality, and program teams.

The candidate will drive post-approval submissions, manage change strategies, and ensure compliance with FDA/EMA/ICH guidelines, mentoring junior staff and coordinating with authorities as needed.