Associate Director, Regulatory Affairs - CMC

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.

DUTIES AND 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.

EDUCATION AND EXPERIENCE:

• 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.

JOB SPECIFICATIONS:

• Strategic Thinking: Ability to evaluate regulatory, technical, and business considerations to develop practical, risk-based strategies that support both program objectives and long-term organizational goals.
• Communication Skills: Exceptional written, verbal, and presentation skills with the ability to effectively communicate complex technical, scientific, and regulatory concepts to diverse audiences, including senior leadership and regulatory authorities.
• 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.
• 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.
• Complex Problem Solving: Ability to analyze ambiguous or highly complex situations, assess interdependencies and risks, and develop effective solutions using sound judgment and a comprehensive understanding of business objectives.
• Influence and Leadership: Demonstrated ability to influence decisions, build alignment, and gain commitment across functions, leadership levels, and external stakeholders without direct authority.
• Collaboration and Relationship Building: Ability to establish productive partnerships across functional areas, foster open communication, and navigate competing priorities to achieve shared objectives.
• Decision Making and Judgment: Demonstrated ability to make timely, informed, and balanced decisions that align regulatory requirements, patient safety, product quality, and business objectives.
• 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 accommodations may be made to enable people with disabilities to perform the essential functions of the job.

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 $188,026.65 - $229,810.30 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.