Associate Director, Regulatory Affairs - CMC

Aspen Neuroscience•San Diego, CA

6d•$188,027 - $229,810•Onsite

About The Position

The Associate Director of Regulatory Affairs, Chemistry Manufacturing Controls (CMC) provides both strategic and operational support for global CMC regulatory activities supporting the Company’s cell therapy products and associated delivery devices from clinical development through marketing application and lifecycle management. This role develops and executes CMC regulatory strategies, leads high-quality submissions and health authority interactions, and serves as the primary regulatory CMC advisor to cross-functional teams. The Associate Director applies advanced regulatory expertise and sound judgment to resolve complex issues, influence program and departmental decisions, manage regulatory risk, and ensure development plans align with current global requirements and business objectives. This is an on-site role in Torrey Pines, CA that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.

Requirements

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 is also preferred.
Biologics experience required; cell or gene therapy experience strongly 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.

Nice To Haves

Advanced degree preferred.
Cell or gene therapy experience strongly preferred.
Medical device experience is also preferred.
Experience interacting with global health authorities and leading cross-functional regulatory initiatives preferred.

Responsibilities

Serve as the regulatory CMC lead for assigned programs, translating company and program objectives into clear regulatory plans, priorities, decision points, and deliverables.
Develop, lead, and execute global CMC regulatory strategies for assigned cell therapy products and associated delivery devices across clinical development, marketing application, and lifecycle management.
Lead the planning, preparation, review, and submission of high-quality CMC content, including IND Module 3, IMPD, briefing materials, responses to information requests, amendments, annual reports, and applicable marketing application content.
Monitor and interpret evolving global requirements, guidance, precedent, and agency expectations for cell and gene therapies, biologics, and medical devices; translate developments into program and policy recommendations.
Identify, assess, communicate, and mitigate regulatory risks, uncertainties, and interdependencies; develop practical contingency plans and escalate matters of significance with clear recommendations.
Provide regulatory assessment and strategic guidance for change controls, deviations, comparability, specifications, validation, stability, and GMP or quality investigations throughout development and commercialization readiness.
Lead CMC interactions with FDA and other global health authorities, including development of meeting strategies, briefing packages, response positions, negotiation approaches, and follow-up commitments.
Provide authoritative regulatory guidance to Technical Operations, Manufacturing, Process Development, Analytical Development, Quality, Clinical, Nonclinical, and other partners; align stakeholders and influence decisions without relying on formal authority.
Establish and manage CMC regulatory timelines, submission plans, priorities, and resource needs to ensure corporate schedules and quality expectations are met.
Represent Regulatory Affairs in cross-functional governance and planning forums, communicate complex issues and recommendations to senior leadership, and support timely, well-informed decisions.
Provide regulatory direction and oversight to consultants, vendors, partners, and collaborators supporting CMC regulatory deliverables.
Provide functional leadership, coaching, and development to regulatory team members and project contributors; support a collaborative, accountable, and high-performing culture.