Sr Manager, Regulatory Affairs CMC

Scorpion Therapeutics; Thousand Oaks (CA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Lead CMC Regulatory Strategist to guide regulatory strategy for autologous T-cell and LVV programs, ensuring lifecycle management and global submissions across development stages.

You will define CMC content, support process changes, and author regulatory documents for INDs, BLAs, and supplements, leading responses to health authority inquiries with a cross-functional team.

Qualifications

• Bachelor's degree with 8+ years in biotech/pharma regulatory affairs or an advanced degree.
• Strong background in cell and gene therapy, GMP, ICH, and regional regulatory requirements.
• Hands-on experience with autologous T-cell and LVV manufacturing processes.
• Proven ability to develop and execute global regulatory strategies.

Responsibilities

• guide regulatory aspects of autologous T-cell manufacturing, LVV production, and lifecycle management
• define phase-appropriate CMC content
• support process changes and comparability strategies
• author and review regulatory documents for INDs, BLAs, and supplements
• lead responses to health authority inquiries

Skills

Regulatory strategy

Global regulatory affairs

GMP/ICH experience

Cell & gene therapy

Education

Bachelor's degree

Advanced degree in regulatory science

Job description

Role

Lead CMC regulatory strategy and program leadership for cell therapy and viral vector products, including T-cell drug and LVV manufacturing.

Objectives

ensure regulatory alignment across early to late-stage development, registration, and post-approval activities, facilitating global submissions and inspections.

Responsibilities

• guide regulatory aspects of autologous T-cell manufacturing, LVV production, and lifecycle management
• define phase-appropriate CMC content
• support process changes and comparability strategies
• author and review regulatory documents for INDs, BLAs, and supplements
• lead responses to health authority inquiries

Qualifications

• Bachelor's degree with 8+ years or advanced degrees with relevant experience in biotech/pharma, regulatory affairs, or related fields
• strong background in cell and gene therapy, GMP, ICH, and regional requirements
• hands-on experience with autologous T-cell and LVV manufacturing processes
• proven ability to develop and execute global regulatory strategies

High-Value

• expertise in CAR T-cell therapies, viral vectors, process validation, analytical method development, and lifecycle management of advanced therapies
• experience supporting early clinical, pivotal, and commercial programs
• familiarity with international regulatory submissions and multi-site manufacturing

WorkSetup

hybrid model based in Santa Monica, CA, with planned relocation to CA offices by 2027; supports flexible work policies.