Associate Director, Global Regulatory CMC – Cell Therapy

BioSpace; San Diego (CA); On-site; USD 188,000 - 230,000; Full time

Benefits offered by this job

Competitive total compensation

Medical/Dental insurance

Onsite gym

Job summary

Aspen Neuroscience in Torrey Pines, CA, seeks an Associate Director of Regulatory Affairs (CMC) to lead global CMC regulatory strategies for cell therapy products and delivery devices across clinical development and lifecycle management. You will drive high-quality submissions and health authority interactions as the primary CMC advisor to cross-functional teams.

The role requires advanced regulatory expertise, 8+ years of experience, and significant biologics/cell/gene therapy exposure.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field; advanced degree preferred.
• Minimum of 8 years of regulatory affairs experience in biotech/pharma/medical devices, with significant CMC experience.
• Biologics experience required; cell or gene therapy experience strongly preferred.

Responsibilities

• Lead global CMC regulatory strategies for cell therapy products and devices across development, regulatory submissions, and lifecycle management.
• Prepare and submit CMC content (IND Module 3, IMPD, briefing materials, responses, amendments, annual reports).
• Provide regulatory guidance to cross-functional teams and manage regulatory risk and timelines.

Skills

Strategic thinking

Communication

CMC regulatory expertise

Biologics knowledge

Cell/gene therapy experience

IND/CTA submissions

Regulatory risk management

Cross-functional leadership

Planning and execution

Regulatory guidance

Education

Bachelors in Life Sciences/Related field

Regulatory affairs experience (8+ years)

Tools

Microsoft Office

Adobe Acrobat

Job description

Aspen Neuroscience in Torrey Pines, CA, seeks an Associate Director of Regulatory Affairs (CMC) to lead global CMC regulatory strategies for cell therapy products and delivery devices across clinical development and lifecycle management. You will drive high-quality submissions and health authority interactions as the primary CMC advisor to cross-functional teams.

The role requires advanced regulatory expertise, 8+ years of experience, and significant biologics/cell/gene therapy exposure.