Associate Director, CMC Regulatory Strategy – Cell Therapy

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

Job summary

Aspen Neuroscience, Inc. in San Diego, CA, is seeking an Associate Director of Regulatory Affairs (CMC) to lead strategic and operational CMC activities for biologics cell therapies and delivery devices from development through lifecycle management.

This on-site role requires collaboration with cross-functional teams and interactions with global authorities. The candidate will develop regulatory strategies, manage submissions (IND Module 3, IMPD), lead risk assessment, and mentor staff while

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related scientific discipline required; advanced degree preferred.
• Minimum of 8 years of regulatory affairs experience within biotechnology, pharmaceuticals, medical devices, or related industries, including significant CMC regulatory experience.
• Biologics experience required; cell or gene therapy experience strongly preferred. Medical device experience is also preferred.
• Experience leading CMC content for INDs, CTAs, and other regulatory submissions required.
• Experience interacting with global health authorities and leading cross-functional regulatory initiatives preferred.

Responsibilities

• Serve as the regulatory CMC lead for assigned programs and develop regulatory plans and deliverables.
• Develop, lead, and execute global CMC regulatory strategies for cell therapy products and associated devices.
• Lead preparation and submission of high-quality CMC content (IND Module 3, IMPD, etc.).
• Monitor evolving global requirements and translate them into program recommendations.
• Identify and mitigate regulatory risks; develop contingency plans and elevate significant matters.
• Provide regulatory guidance for change controls, deviations, comparability, specs, validation, and investigations.
• Lead CMC interactions with FDA and global authorities; develop meeting strategies and responses.
• Provide regulatory direction to cross-functional partners and align stakeholders without formal authority.
• Establish CMC timelines, submission plans, and resource needs.
• Represent Regulatory Affairs in governance forums and support senior leadership decisions.
• Provide leadership and development to regulatory staff and contributors.

Skills

Strategic thinking

Communication

CMC regulatory expertise

Cross-functional collaboration

Leadership

Education

Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field

Advanced degree preferred

Tools

Microsoft Office

Adobe Acrobat

Job description

Aspen Neuroscience, Inc. in San Diego, CA, is seeking an Associate Director of Regulatory Affairs (CMC) to lead strategic and operational CMC activities for biologics cell therapies and delivery devices from development through lifecycle management.

This on-site role requires collaboration with cross-functional teams and interactions with global authorities. The candidate will develop regulatory strategies, manage submissions (IND Module 3, IMPD), lead risk assessment, and mentor staff while