Executive Director, CMC Regulatory Science

Location: Norwood, Massachusetts, United States; 70% in-office work model

Company

hirify.global develops mRNA-based therapeutics and vaccines through its technology platform, delivery technology, manufacturing capabilities, and development pipeline.

What you will do

• Lead a team of CMC experts developing and implementing regulatory strategies for IND, CTA, BLA, and MAA submissions.
• Oversee CMC and Quality agency correspondence, regulatory applications, and product strategies across multiple programs.
• Review submission documents for readiness, regulatory compliance, and alignment with health authority requirements.
• Lead expert-level CMC discussions and interactions with health authorities to support submission review and approval.
• Develop regulatory processes and maintain CMC submission templates.
• Advise manufacturing, quality, process development, and analytical development groups on regulatory guidance, regulations, directives, and CMC change controls.

Requirements

• MS or PhD in a scientific or engineering discipline; molecular biology, pharmaceutics, or chemistry is preferred.
• 10+ years of experience in the pharmaceutical or biotech industry.
• 8+ years of Regulatory CMC experience, including DMF/ASMF submissions.
• Strong knowledge of current US, EU, and rest-of-world regulations.
• Strong experience with CTD format and regulatory filing content.
• Exceptional written and oral communication skills.

Nice to have

• More than 10 years of experience with manufacturing and/or analytical functions.
• At least 8 years of biologics-focused Regulatory CMC experience.
• Experience across vaccines, oncology, or rare-disease therapeutic areas.

Culture & Benefits

• 70% in-office collaboration with an in-person working model.
• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, and mental health resources.
• Family planning support, including fertility, adoption, and surrogacy benefits.
• Paid vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment opportunities plus location-specific benefits.