Job Description

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

Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below.

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 xywuqvp 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

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