Senior Director, Regulatory CMC (Biologics)

Location: South San Francisco, United States. Full-time hybrid role with a strong preference for working on-site at least two days per week in the San Francisco-based office; travel may be required up to 10%.

Salary: $260,000–$295,000 per year.

Company

hirify.global is a clinical-stage biotechnology company developing therapies for genetically validated cardioendocrine disease targets, including severe hypertriglyceridemia and acromegaly.

What you will do

• Provide strategic Regulatory CMC leadership across product development, manufacturing, and commercialization programs.
• Partner with Technical Operations, Manufacturing, Quality, Supply Chain, Device Development, and other cross-functional stakeholders.
• Develop manufacturing and control strategies, assess process and analytical method changes, and provide guidance on comparability and phase-appropriate requirements.
• Lead CMC strategies for biologics and drug-device combination products, including pre-filled syringes and autoinjectors.
• Prepare and submit CMC briefing documents and regulatory application sections in the US and globally.
• Lead health-authority communications, manage information requests, monitor regulatory trends, and build the future Regulatory CMC function.

Requirements

• 15+ years of pharmaceutical or biotechnology industry experience, including at least 10 years in CMC Regulatory Affairs for biologics.
• Direct experience supporting monoclonal antibody development and leading CMC interactions with regulatory health authorities.
• Experience creating and submitting CTA/IND and BLA/MAA filings for biologics.
• Bachelor’s degree in biochemistry, chemistry, biology, or a related pharmaceutical field; an advanced degree is preferred.
• Strong knowledge of GMP, biologics development regulations, and ICH, FDA, and EMA guidance.
• Experience with drug-device combination products or device constituent parts, including 21 CFR Part 4, design control, human factors, and EU MDR Article 117 requirements.

Nice to have

• Pre-commercial through launch experience.
• Experience working in a small-company environment.

Culture & Benefits

• Collaborative, hands-on environment with direct contribution across organizational levels.
• Opportunity to shape and grow the Regulatory CMC function.
• Dynamic work environment with cross-functional leadership responsibilities.
• Travel of up to 10% for conferences, regulatory interactions, and company meetings.