Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC)

Location: Hybrid, based at the San Diego headquarters in the United States

Salary: $164,000–$205,000 for Associate Director; $196,000–$245,000 for Director

Company

hirify.global is a clinical-stage life-science and technology company developing medicines through an AI-driven discovery and development platform.

What you will do

• Develop and execute global CMC regulatory strategies covering drug substance, drug product, analytical methods, manufacturing processes, controls, specifications, stability, packaging, and lifecycle activities.
• Lead the planning, authoring, review, coordination, and delivery of CMC content for INDs, CTAs, amendments, annual reports, briefing packages, health authority responses, and other global filings.
• Partner with Technical Operations, Process Chemistry, Analytical Development, Formulation, Manufacturing, Quality, Clinical, Nonclinical, Regulatory Operations, and external development and manufacturing organizations.
• Provide phase-appropriate guidance on control strategies, comparability, specifications, stability, manufacturing changes, technology transfer, process validation, and later-stage readiness.
• Represent hirify.global in CMC-focused interactions with the US FDA and other global health authorities, including meeting preparation, briefing materials, responses, and commitments.
• Monitor global CMC regulations, identify risks and dependencies, develop mitigation strategies, and support due diligence, partnerships, vendor oversight, procedures, systems, consultants, and staffing plans.

Requirements

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or a related discipline; an advanced degree is preferred.
• Typically 8+ years of relevant pharmaceutical or biotechnology experience for Associate Director or 10+ years for Director, including substantial CMC regulatory affairs experience.
• Experience developing CMC regulatory strategy and preparing or reviewing Module 3/Quality content for clinical-stage submissions; small-molecule experience is preferred.
• Strong knowledge of global CMC requirements and FDA and ICH guidance.
• Ability to manage multiple programs and workstreams, set priorities, maintain submission timelines, and deliver high-quality work in a fast-paced, cross-functional environment.
• Strong scientific writing, communication, collaboration, project management, problem-solving, and attention-to-detail skills, with proficiency in regulatory submission tools and Microsoft Office.

Culture & Benefits

• Inclusive environment focused on diversity of backgrounds, cultures, national origins, religions, sexual orientations, and life experiences.
• Company-paid healthcare, flexible spending accounts, voluntary life insurance, and 401(k) matching.
• Uncapped vacation.
• Work in a new facility with an onsite gym and dining.
• Mission-driven work combining AI-based discovery technologies with therapeutic development.