Senior Regulatory CMC Lead – Cell Therapy

Aspen Neuroscience, Inc.; San Diego (CA); On-site; USD 188,000 - 230,000; Full time

Benefits offered by this job

Competitive total compensation package

Paid time off + holidays

Medical/Dental insurance

Onsite gym

Wellness perks

Job summary

Aspen Neuroscience, Inc. in San Diego, CA, seeks an Associate Director of Regulatory Affairs, CMC, to provide strategic and operational leadership for global CMC regulatory activities from clinical development through launch and lifecycle management.

You will drive high‑quality submissions and health authority interactions while guiding cross‑functional teams. The role requires advanced CMC expertise, Biologics/cell/gene therapy experience, and a track record of regulatory leadership in biotech.

Qualifications

• Bachelors degree in Life Sciences, Pharmacy, Engineering, or related discipline; advanced degree preferred.
• Minimum of 8 years of regulatory affairs experience, including significant CMC content.
• Biologics and cell/gene therapy experience strongly preferred; medical device exposure beneficial.
• Experience leading CMC content for INDs/CTAs and global submissions.

Responsibilities

• Lead global CMC regulatory strategies for cell therapy products and delivery devices.
• Manage planning, preparation, review, and submission of CMC content (IND Module 3, IMPD, briefing materials).
• Provide regulatory guidance to cross-functional partners and manage timelines and risk.
• Lead interactions with FDA and other health authorities and develop meeting strategies.

Skills

Regulatory Affairs

CMC Expertise

Leadership

Cross-functional Leadership

Education

Bachelors degree in Life Sciences or related

Tools

Microsoft Office

Adobe Acrobat

Job description

Aspen Neuroscience, Inc. in San Diego, CA, seeks an Associate Director of Regulatory Affairs, CMC, to provide strategic and operational leadership for global CMC regulatory activities from clinical development through launch and lifecycle management.

You will drive high‑quality submissions and health authority interactions while guiding cross‑functional teams. The role requires advanced CMC expertise, Biologics/cell/gene therapy experience, and a track record of regulatory leadership in biotech.