Associate Director Regulatory Affairs, CMC

About the role

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.

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.
• 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.