Director, Regulatory CMC

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

Role: Director, Regulatory CMC, leading global lifecycle and change management strategies for approved and late-stage gene therapy products.

Responsibilities

• oversee post-approval CMC activities including submission of supplements, variations, and reports
• develop and implement change management strategies
• support manufacturing, supply continuity, inspection readiness, and regulatory interactions with authorities (FDA, EMA)
• author and review CMC documentation
• ensure compliance with global regulatory standards
• monitor emerging guidance and inspection trends
• mentor junior team members
• collaborate cross-functionally with Tech Ops, Quality, Supply Chain, and Program teams

Qualifications

• Bachelor’s or Master’s in life sciences
• 10-12+ years in biopharmaceutical CMC regulatory affairs, particularly biologics or gene therapies
• experience with post-approval submissions and global regulatory frameworks (FDA, EMA, ICH)
• strong communication, organizational, and cross-functional collaboration skills

High-Value

• gene therapy
• post-approval lifecycle management
• global regulatory compliance
• GMP
• CMC change strategies
• inspection readiness

Work Setup: hybrid in Somerville, MA; no travel specified.