Director, Regulatory Affairs - CMC

Aspen Neuroscience•San Diego, CA

9h•$207,000 - $253,000

About The Position

The Director of Regulatory Affairs, Chemistry Manufacturing Controls (CMC) provides strategic leadership and functional ownership for global CMC regulatory activities supporting the Company’s cell therapy products and associated delivery devices. The role spans clinical development through marketing application, commercialization readiness, and lifecycle management. It establishes and directs CMC regulatory strategy for assigned programs and focus areas and serves as the senior CMC regulatory advisor to executive and cross-functional leaders. The Director is accountable for regulatory decision quality, health authority engagement, organizational alignment, and management of significant CMC regulatory risks, policies, priorities, resources, and deliverables that affect program and departmental success. This is a hybrid or remote role requiring flexibility and availability for weekend and holiday work as needed. Relocation is not available. The position is based in a general office environment, with extended periods of desk work and computer use. The anticipated annual salary range for candidates working in San Diego is $207,000–$253,000; the final offer depends on factors such as experience and education, and the stated range may not apply to positions in other states.

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related scientific discipline.
At least 10 years of progressively responsible regulatory affairs experience in biotechnology, pharmaceuticals, medical devices, or related industries, including significant CMC regulatory experience.
Experience independently leading global CMC regulatory strategy and content for INDs, CTAs, and major health authority interactions.
Biologics experience.
Advanced knowledge of global CMC regulations, guidance, and agency expectations, including FDA, EMA, MHRA, Health Canada, and ICH requirements applicable to biologics and advanced therapies.
Ability to translate company objectives into CMC regulatory strategies, operating priorities, and decisions that support program and functional goals.
Ability to resolve ambiguous, high-impact issues by evaluating regulatory, technical, quality, patient, and business considerations.
Ability to communicate complex matters clearly, influence senior leaders and external stakeholders, negotiate effectively, and build alignment around significant decisions.
Ability to integrate differing perspectives, resolve competing priorities, and lead complex initiatives across functions.
Understanding of the product development lifecycle, the role of CMC within drug development, and the broader biotechnology and competitive landscape.
Strong organizational and project management skills, including the ability to manage multiple priorities, anticipate challenges, and drive critical deliverables to completion.
Proficiency in Microsoft Office Suite, Adobe Acrobat, and systems commonly used for regulatory documentation, submissions, and information management.
Valid work authorization that does not require employer sponsorship now or in the future; the company is unable to provide visa sponsorship.

Nice To Haves

Advanced degree in a scientific discipline.
Experience supporting BLA, NDA, MAA, or equivalent marketing applications.
Cell or gene therapy experience.
Medical device experience.
Experience interacting with global health authorities and leading cross-functional regulatory initiatives.

Responsibilities

Own and direct CMC regulatory strategy for assigned cell therapy products, associated delivery devices, and regulatory focus areas across clinical development, marketing application, commercialization readiness, and lifecycle management.
Translate company and functional objectives into integrated CMC regulatory plans, decision frameworks, operating priorities, resource requirements, and measurable deliverables; make final recommendations on methods, approaches, and evaluation criteria within the assigned scope.
Lead planning, preparation, review, and submission of CMC content, including IND Module 3, IMPD, briefing materials, responses to information requests, amendments, annual reports, and applicable marketing application and lifecycle content.
Establish CMC regulatory positions and precedents by interpreting evolving global requirements, guidance, industry trends, and agency expectations for cell and gene therapies, biologics, and medical devices; translate developments into program and policy recommendations.
Direct identification, assessment, communication, and mitigation of significant regulatory risks, uncertainties, and interdependencies; develop contingency strategies and escalate critical matters with business and regulatory recommendations.
Provide senior-level regulatory direction for change controls, deviations, comparability, specifications, validation, stability, and GMP or quality investigations throughout development and commercialization readiness.
Lead CMC interactions and negotiations with the FDA and other global health authorities, including meeting strategy, briefing packages, response positions, negotiation parameters, commitments, and follow-through.
Serve as senior CMC regulatory advisor to Technical Operations, Manufacturing, Process Development, Analytical Development, Quality, Clinical, Nonclinical, and other partners; resolve competing priorities and build alignment on significant matters.
Represent Regulatory Affairs in cross-functional governance and planning forums and communicate complex issues and recommendations to senior leadership to support timely, informed decisions.
Establish and oversee CMC regulatory operating plans, submission schedules, budgets, priorities, quality standards, processes, and internal and external resource models; strengthen inspection and submission readiness, knowledge management, and execution effectiveness.
Direct employees, consultants, vendors, partners, and collaborators supporting CMC regulatory deliverables; define expectations, evaluate quality and performance, and ensure accountability for outcomes.
Build regulatory capability through people leadership, coaching, succession and development planning, and oversight of project contributors; foster a collaborative, accountable, high-performing team culture.