Sr. Director, Regulatory CMC

Scorpion Therapeutics; Boston (MA); Hybrid; USD 300,000 - 520,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Director of Regulatory CMC to oversee global lifecycle management of approved and late-stage gene therapy products, focusing on post-approval activities, change management, and regulatory compliance.

You will develop and execute strategies for post-approval submissions, oversee manufacturing and analytical change management, and lead interactions with health authorities (FDA, EMA) while mentoring the Regulatory CMC team.

Qualifications

• Bachelor's or Master's in life sciences required; 15+ years in biopharma with post-approval CMC in cell/gene therapies.
• Proven track record leading regulatory submissions and inspections.
• Deep knowledge of GMP, CMC regulations and global regulatory frameworks.

Responsibilities

• Develop and execute post-approval submissions (supplements, variations, annual reports).
• Oversee change management for manufacturing and analytical processes.
• Lead interactions with health authorities (FDA, EMA).
• Mentor the Regulatory CMC team and ensure inspection readiness.

Skills

Regulatory leadership

Post-approval CMC expertise

Strategic thinking

Cross-functional leadership

Inspection readiness

Education

Bachelor's or Master's in life sciences

Job description

Role:

Senior Director of Regulatory CMC responsible for global lifecycle management of approved and late-stage gene therapy products, focusing on post-approval activities, change management, and regulatory compliance.

Responsibilities:

• develop and execute strategies for post-approval submissions (supplements, variations, annual reports)
• oversee change management for manufacturing and analytical processes
• lead interactions with health authorities (FDA, EMA)
• ensure inspection readinessmentor the Regulatory CMC team

Requirements:

• Bachelor's or Master's in life sciences
• minimum 15 years in biopharma with extensive post-approval CMC experience in cell and gene therapies
• proven track record leading regulatory submissions and inspections
• in-depth knowledge of GMP, CMC regulations, and global frameworks

Preferred:

• PhD
• strong leadership skills
• strategic thinking
• experience supporting commercial manufacturing of complex biologics or gene therapies

High-Value:

• extensive post-approval CMC lifecycle expertise
• gene therapy focus
• regulatory leadership in a global context
• cross-functional collaboration

Work Setup:

• hybrid in Somerville, MA
• travel details not specified