Executive Director, CMC Regulatory Science (Biotech)

Location: Norwood, Massachusetts, United States. The role follows a 70/30 work model with significant in-office collaboration.

Salary: $224,900–$404,600 per year, plus potential bonus, incentive compensation, or equity.

Company

hirify.global develops an mRNA technology platform and medicines intended to transform how treatments are created and delivered.

What you will do

• Lead a team developing and implementing CMC regulatory strategies for IND, CTA, BLA, and MAA submissions.
• Oversee product strategy and regulatory activities across multiple programs and therapeutic areas, including vaccines, oncology, and rare diseases.
• Review regulatory documents for submission readiness and alignment with health-authority guidelines.
• Lead expert-level CMC discussions and interactions with health authorities to support submission review and approval.
• Develop regulatory processes, procedures, and templates for CMC submissions.
• Advise manufacturing, quality, process development, and analytical development groups on regulations, guidance, and CMC change controls.

Requirements

• MS or PhD in a scientific or engineering discipline; molecular biology, pharmaceutics, chemistry, or a related field is desirable.
• 10+ years of experience in the pharmaceutical or biotech industry.
• 8+ years of Regulatory CMC experience, including DMF and ASMF submissions.
• Strong knowledge of current US, EU, and rest-of-world regulations and extensive experience with CTD regulatory filings.
• Experience in biologics-focused Regulatory CMC, manufacturing, or analytical development.
• Only U.S. persons can currently access export-controlled information without an export license; other candidates may be considered subject to licensing.

Culture & Benefits

• In-person collaboration is supported through a 70/30 in-office work model.
• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, mental-health, and other well-being resources.
• Family-planning benefits, including fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment opportunities.