Senior Director, Regulatory CMC

Location: South San Francisco; strong preference for working onsite at least two days per week in the San Francisco-based office

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 activities in the US and globally.
• Partner with Technical Operations, Manufacturing, Quality, Supply Chain, Device Development, and other cross-functional stakeholders.
• Guide manufacturing and control strategies, process and analytical method changes, comparability assessments, and phase-appropriate regulatory decisions.
• Lead CMC regulatory strategy for drug-device combination products, including pre-filled syringes and autoinjectors.
• Prepare and submit CMC briefing documents and regulatory application sections, and lead communications with health authorities.
• Identify and mitigate regulatory risks while building the Regulatory CMC function and future team.

Requirements

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

Nice to have

• Pre-commercial through launch experience in a small-company environment.
• Experience building high-functioning teams and developing Regulatory CMC capabilities.

Culture & Benefits

• Hands-on, collaborative environment with close interaction across organizational levels.
• Fast-paced work with tight deadlines and opportunities to shape a growing function.
• Up to 10% travel for conferences, regulatory interactions, and company or department meetings.