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Aspen Neuroscience seeks an Associate Director of Regulatory Affairs, Chemistry Manufacturing Controls (CMC) to lead global regulatory strategy and execution for cell therapy products and associated delivery devices. This role bridges clinical development, marketing applications, and lifecycle management, serving as the primary CMC regulatory advisor to cross-functional teams.
Key responsibilities include developing and executing CMC regulatory strategies for assigned programs; leading preparation and submission of high-quality CMC content (IND Module 3, IMPD, briefing materials, responses to information requests, amendments, annual reports, and marketing application submissions); monitoring and interpreting evolving global requirements for cell and gene therapies, biologics, and medical devices; identifying and mitigating regulatory risks and interdependencies; providing regulatory assessment on change controls, deviations, comparability, specifications, validation, stability, and GMP investigations; leading FDA and global health authority interactions; providing authoritative guidance to Technical Operations, Manufacturing, Process Development, Analytical Development, Quality, Clinical, and Nonclinical teams; establishing CMC regulatory timelines and submission plans; representing Regulatory Affairs in cross-functional governance forums; managing consultants and vendors; and providing functional leadership and coaching to regulatory team members.
Required qualifications: Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related scientific discipline; minimum 8 years of regulatory affairs experience in biotechnology, pharmaceuticals, medical devices, or related industries with significant CMC regulatory experience; biologics experience required; experience leading CMC content for INDs, CTAs, and other regulatory submissions. Preferred: advanced degree; cell or gene therapy experience; medical device experience; experience interacting with global health authorities; experience leading cross-functional regulatory initiatives.
Essential competencies include strategic thinking, exceptional communication skills (written, verbal, presentation), advanced CMC regulatory expertise (FDA, EMA, MHRA, Health Canada, ICH), business acumen, complex problem-solving, influence and leadership without direct authority, collaboration and relationship building, sound judgment, and strong planning and execution capabilities.
This is an on-site role in Torrey Pines, CA requiring flexibility for weekend and holiday work as needed. Relocation assistance is not available.
