Strategic CMC Regulatory Lead — Cell Therapy

Valid8 Financial, Inc.; San Diego (CA); Hybrid; USD 188,000 - 230,000; Full time

Benefits offered by this job

Medical/Dental insurance benefits

Onsite gym

Time off + company holidays

Job summary

Aspiring to join Aspen Neuroscience, Inc. as Associate Director of Regulatory Affairs, CMC? This on-site role in Torrey Pines, San Diego, supports global CMC regulatory activities for cell therapy products and delivery devices from development through lifecycle management.

The role requires advanced regulatory expertise, leadership, and bold collaboration with cross-functional teams; regulators interactions with FDA and global authorities are key, with weekend/holiday flexibility noted.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a 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 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, translating objectives into regulatory plans, priorities, decision points, and deliverables.
• Develop, lead, and execute global CMC regulatory strategies for cell therapy products and delivery devices across development, applications, and lifecycle management.
• Lead planning, preparation, review, and submission of high-quality CMC content (IND Module 3, IMPD, briefing materials, responses, amendments, annual reports).
• Monitor and interpret evolving global requirements and translate into program recommendations.
• Identify, assess, communicate, and mitigate regulatory risks; develop contingency plans and escalate significant matters with recommendations.
• Provide regulatory guidance for change controls, deviations, comparability, specifications, validation, stability, and GMP investigations.
• Lead CMC interactions with FDA and global health authorities; develop meeting strategies and briefing packages.
• Provide regulatory guidance to cross-functional partners; align stakeholders without formal authority.
• Establish and manage CMC regulatory timelines, submission plans, priorities, and resources.
• Represent Regulatory Affairs in governance forums and communicate with senior leadership.
• Provide oversight to consultants and vendors; coach and develop regulatory team members.

Skills

Strategic thinking

Communication skills

CMC regulatory expertise

Business acumen

Complex problem solving

Influence and leadership

Collaboration and relationship

Decision making and judgment

Planning and execution

Technical proficiency

Education

Bachelor's degree in Life Sciences/Pharmacy/Engineering

Advanced degree preferred

Biologics/cell/gene therapy experience

Tools

Microsoft Office

Adobe Acrobat

Job description

Aspiring to join Aspen Neuroscience, Inc. as Associate Director of Regulatory Affairs, CMC? This on-site role in Torrey Pines, San Diego, supports global CMC regulatory activities for cell therapy products and delivery devices from development through lifecycle management.

The role requires advanced regulatory expertise, leadership, and bold collaboration with cross-functional teams; regulators interactions with FDA and global authorities are key, with weekend/holiday flexibility noted.