Director, Regulatory Affairs - CMC

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 from clinical development through marketing application, commercialization readiness, and lifecycle management. This role 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 the management of significant CMC regulatory risks, policies, priorities, resources, and deliverables that affect program and departmental success.This is a Hybrid or Remote role that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.

DUTIES AND RESPONSIBILITIES:

• Own and Direct CMC regulatory strategy for assigned cell therapy products, associated delivery devices, and regulatory focus areas across clinical dev, marketing application, commercialization readiness and lifecycle mgmt.

• 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 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, 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 the Identification, assessment, communication, and mitigation of significant regulatory risks, uncertainties, and interdependencies; develop practical contingency strategies and escalate critical matters with clear 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 FDA and other global health authorities, including meeting strategy, briefing packages, response positions, negotiation parameters, commitments, and follow-through.

• Serve as the 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 matters significant to program and company objectives.

• Represent Regulatory Affairs in cross-functional governance and planning forums, communicate complex issues and recommendations to senior leadership, to enable timely, well-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 to meet corporate requirements.

• Direct the work of 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, and high-performing team culture.

EDUCATION AND EXPERIENCE:

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related scientific discipline required; advanced degree preferred.

• Minimum of 10 years of progressively responsible regulatory affairs experience within biotechnology, pharmaceuticals, medical device, 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 required; experience supporting BLA, NDA, MAA, or equivalent marketing applications strongly preferred.

• Biologics experience required; cell or gene therapy experience strongly preferred. Medical device experience preferred.

• Experience interacting with global health authorities and leading cross-functional regulatory initiatives preferred.

JOB SPECIFICATIONS:

• CMC Regulatory Expertise: 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.

• Strategic Leadership: Ability to translate company objectives into CMC regulatory strategies, operation priorities and decisions that support program and functional goals.

• Judgment and Problem Solving: Ability to resolve ambiguous, high-impact issues by evaluating regulatory, technical, quality, patient, and business considerations.

• Executive Influence and Communication: Ability to communicate complex matters clearly, influence senior leaders and external stakeholders, negotiate effectively, and build alignment around significant decisions

• Cross-Functional Leadership: Ability to integrate differing perspectives, resolve competing priorities, and lead complex initiatives across functions without relying solely on formal authority.

• Business Acumen: Understanding of the product development lifecycle, the role of CMC within drug development, and the broader biotechnology and competitive landscape to inform decision-making and prioritization.

• Planning and Execution: Strong organizational and project management skills with the ability to manage multiple priorities, anticipate challenges, and drive critical deliverables to completion in a dynamic environment.

• Technical Proficiency: Proficient in Microsoft Office Suite, Adobe Acrobat, and other systems commonly used for regulatory documentation, submissions, and information management

WORKING CONDITIONS

General Office Environment. This is an indoor position that requires sitting at a desk for extended periods of time and the ability to type and use a computer. The noise level in the work environment is usually quiet to moderate.

PHYSICAL DEMANDS

While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job

EEO and Employment Eligibility:

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees. Aspen is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future.

Total Rewards and Culture:

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.

The anticipated salary range for candidates who will work in San Diego is $207,000 - $253,000 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.