Remote CMC Regulatory Strategy Director, Cell Therapy

Aspen Neuroscience, Inc.; San Diego (CA); Hybrid; USD 207,000 - 253,000; Full time

Benefits offered by this job

Competitive total compensation package

Medical/Dental insurance benefits

Onsite gym and wellness perks

Job summary

Aspen Neuroscience, Inc. in San Diego, CA, is seeking a Director of Regulatory Affairs, CMC, to lead global CMC regulatory strategy for cell therapy products and delivery devices.

The role spans from clinical development to lifecycle management, interfacing with FDA and other health authorities for INDs, CTAs, and major submissions. The ideal candidate will have 10+ years in regulatory affairs, biologics/cell/gene therapy experience, and strong leadership and cross-functional collaboration

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related scientific discipline required.
• Minimum of 10 years of progressively responsible regulatory affairs experience within biotechnology, pharmaceuticals, medical device, or related industries, including significant CMC regulatory experience.
• Experience independently leading global CMC regulatory strategy and content for INDs, CTAs, and major health authority interactions required; experience supporting BLA, NDA, MAA, or equivalent marketing applications strongly preferred.
• Biologics experience required; cell or gene therapy experience strongly preferred. Medical device experience preferred.
• Experience interacting with global health authorities and leading cross-functional regulatory initiatives preferred.

Responsibilities

• Own and Direct CMC regulatory strategy for assigned cell therapy products and devices across clinical dev, marketing, and lifecycle mgmt.
• Translate objectives into integrated CMC regulatory plans with measurable deliverables.
• Lead planning, preparation, review, and submission of high-quality CMC content (IND Module 3, IMPD, briefing materials, responses, annual reports).
• Establish CMC regulatory positions and precedents by interpreting evolving global requirements and agency expectations.
• Direct identification, assessment, communication, and mitigation of significant regulatory risks and interdependencies.
• Provide senior level regulatory direction for change controls, deviations, comparability, specifications, validation, and GMP investigations.
• Lead CMC interactions and negotiations with FDA and global authorities, including meeting strategy and positions.
• Serve as senior CMC advisor to cross-functional partners; resolve priorities and align on program objectives.
• Represent Regulatory Affairs in governance forums to enable timely, well-informed decisions.
• Establish and oversee CMC regulatory operating plans, submission schedules, budgets, and readiness.

Skills

CMC regulatory strategy

Regulatory leadership

FDA interactions

Biologics/cell therapy

Regulatory submissions

Cross-functional collaboration

Quality systems compliance

Education

Bachelor's degree in Life Sciences/Pharmacy/Engineering

Advanced degree preferred

Tools

Microsoft Office

Adobe Acrobat

Job description

Aspen Neuroscience, Inc. in San Diego, CA, is seeking a Director of Regulatory Affairs, CMC, to lead global CMC regulatory strategy for cell therapy products and delivery devices.

The role spans from clinical development to lifecycle management, interfacing with FDA and other health authorities for INDs, CTAs, and major submissions. The ideal candidate will have 10+ years in regulatory affairs, biologics/cell/gene therapy experience, and strong leadership and cross-functional collaboration