Director Regulatory Affairs CMC (Fremont)

Director, Regulatory CMC (Hybrid – San Francisco Bay Area)

We are partnering with a well-funded, clinical-stage biotechnology company with a diversified pipeline spanning both biologics and small molecule therapeutics . The organization is advancing multiple programs across early and late-stage development and is building out its Regulatory CMC leadership to support global filings and accelerate programs toward commercialization.

This is a high-impact, strategic leadership role for someone who thrives at the intersection of regulatory strategy, CMC development, and cross-functional program execution in a fast-paced, science-driven environment.

The Director, Regulatory CMC will lead global CMC regulatory strategy and execution across multiple programs, including biologics and small molecules. This individual will serve as a key interface between Regulatory Affairs, CMC, Quality, Technical Operations, and external partners to ensure alignment with global regulatory expectations and successful IND/CTA, BLA, and NDA submissions.

This is a hybrid role based in the San Francisco Bay Area , requiring on-site collaboration several days per week.

Key Responsibilities

• Lead global Regulatory CMC strategy across clinical and late-stage development programs (biologics and small molecules)
• Author, review, and oversee high-quality CMC sections for INDs, IMPDs, CTAs, BLAs, and NDAs
• Provide strategic regulatory guidance on CMC development plans, comparability strategies, process changes, and lifecycle management
• Act as primary CMC regulatory liaison with global health authorities, including FDA and EMA
• Partner closely with Process Development, Manufacturing, Analytical, and Quality teams to ensure regulatory alignment
• Support regulatory responses to agency questions, deficiencies, and inspection readiness activities
• Drive regulatory risk assessments and mitigation strategies for complex CMC issues
• Contribute to development of regulatory policies, templates, and best practices across the organization
• Monitor evolving global regulatory guidance impacting CMC strategy and submissions

Qualifications

• Advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related field (PhD preferred)
• 10+ years of experience in Regulatory Affairs CMC within biotech or pharma
• Demonstrated experience supporting both biologics and small molecule development programs
• Strong track record of successful IND/CTA filings and NDA/BLA submissions
• Deep understanding of CMC regulatory requirements across US, EU, and other global regions
• Experience interacting directly with regulatory agencies (FDA, EMA, and/or other health authorities)
• Strong cross-functional leadership skills in matrixed, fast-paced environments
• Excellent written and verbal communication skills with the ability to influence senior stakeholders

Why This Role

• Opportunity to shape CMC regulatory strategy across a dual-modality pipeline
• High visibility role reporting into senior regulatory leadership
• Strong pipeline momentum with multiple clinical-stage assets
• Collaborative, science-driven culture with significant growth trajectory

If interested, please reach out to [email protected]