Manager, Regulatory Affairs CMC

Scorpion Therapeutics; Santa Monica (CA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Manager, Global Regulatory CMC to oversee regulatory submissions and lifecycle management for our autologous CAR T-cell therapy portfolio. You will lead global CMC activities, author content, and align with regulatory strategies from Santa Monica, with planned relocation and flexibility for remote work.

The role requires deep experience in regulatory CMC, global health authority interactions, and a proactive, organized approach in a fast-paced biotech environment.

Qualifications

• Bachelor's degree plus 6 years or Master's plus 4 years in regulatory CMC or drug development.
• Strong knowledge of global regulatory requirements (FDA, EMA).
• Experience with biologics or cell/gene therapies, especially autologous CAR-T or ATMPs.
• Excellent communication skills.
• Highly organized and adaptable.

Responsibilities

• Lead CMC regulatory activities for INDs, BLAs, MAAs, variations.
• Serve as regulatory lead on cross-functional teams, author and review Module 3 content.
• Develop strategies for process and raw material changes.
• Support interactions with health authorities.

Skills

Regulatory CMC

FDA/EMA knowledge

Biologics/ATMPs

Communication

Organizational skills

Education

Bachelor's degree (Regulatory CMC or Drug Development)

Master's degree (Regulatory CMC or Drug Development)

Job description

Role

Manager, Global Regulatory CMC for Kite's autologous CAR T-cell therapy portfolio, overseeing global regulatory submissions, lifecycle management, and change management aligned with regulatory strategies.

Responsibilities

• Lead CMC regulatory activities for INDs, BLAs, MAAs, variations;
• Serve as the regulatory lead on cross-functional teams, author and review Module 3 content;
• Develop strategies for process and raw material changes;
• Support interactions with health authorities.

Requirements

• Bachelor's degree plus 6 years or Master's plus 4 years in regulatory CMC or drug development;
• Strong knowledge of global regulatory requirements (FDA, EMA);
• Experience with biologics or cell/gene therapies, especially autologous CAR-T or ATMPs;
• Excellent communication skills;
• Highly organized and adaptable.

High-Value

• CAR T-cell therapies, autologous biologics, global regulatory compliance, lifecycle management, IND/BLA/MAA submissions, cross-functional collaboration, innovative cell therapy development.

Work Setup

Based in Santa Monica, CA with flexibility (2 remote days/week) through 2026, planned relocation to Thousand Oaks, Foster City, or El Segundo by 2027; minimal supervision, fast-paced biotech environment.