Associate Director, Global Regulatory Science, CMC

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

Salary: $142,500–$256,500 per year, plus potential bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA technology and medicines across vaccine, oncology, and other therapeutic applications.

What you will do

• Develop and implement CMC regulatory strategies for international IND, CTA, BLA, and MAA submissions.
• Prepare, oversee, and govern CMC and Quality agency correspondence and regulatory applications.
• Review submission documents for readiness and compliance with health authority guidelines.
• Lead CMC regulatory discussions and interactions with health authorities.
• Provide regulatory guidance to manufacturing and Quality teams, including evaluation of CMC change controls.
• Oversee multiple regulatory programs across vaccines, oncology, and rare diseases.

Requirements

• BS degree in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field.
• 10+ years of experience in the pharmaceutical or biotech industry, with manufacturing and/or analytical focus.
• 8+ years of experience in biologics-focused Regulatory CMC.
• Strong knowledge of current EU and rest-of-world regulations, cGMP, and CTD regulatory filings.
• Experience across therapeutic areas such as vaccines, oncology, and/or rare diseases.
• Only U.S. persons—U.S. citizens, permanent residents, asylees, or refugees—are eligible because of U.S. export control requirements; visa sponsorship is not available.

Nice to have

• MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field.

Culture & Benefits

• In-person collaboration supported through a 70/30 work model.
• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, mental health, and family planning support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs, plus location-specific benefits.