Associate Director, Global Regulatory, CMC (Biotech)

Location: Norwood, Massachusetts, United States. The role follows a 70/30 in-office work model and is limited to U.S. persons eligible to access export-controlled information.

Salary: $142,500–$256,500 annually, with potential bonus, incentive compensation, or equity.

Company

hirify.global develops an mRNA technology platform and medicines focused on transforming healthcare.

What you will do

• Develop and implement CMC regulatory strategies for global IND, CTA, BLA, and MAA submissions.
• Identify regulatory risks and provide CMC guidance throughout product development lifecycles.
• Review submission documents for readiness and compliance with health authority guidelines.
• Lead Regulatory CMC discussions and interactions with health authorities to support submission review and approval.
• Assess manufacturing change controls and provide regulatory guidance to manufacturing, quality, and process development groups.
• Develop regulatory processes, procedures, and templates for CMC submissions.

Requirements

• BS, MS, or PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field.
• 8+ years of experience in the pharmaceutical or biotech industry, with a manufacturing or analytical focus.
• 5+ years of experience in biologics-focused Regulatory CMC.
• Strong knowledge of global CMC regulations and CTD format and content.
• Broad experience with CMC regulatory procedures and legislation covering drug development, product registration, line extensions, and license maintenance.
• Must qualify as a U.S. person; hirify.global cannot sponsor non-U.S. persons for an export control license.

Nice to have

• Experience collaborating in dynamic, cross-functional matrix environments.
• Ability to work independently with exceptional written and oral communication skills.
• Experience driving critical regulatory milestones across multiple programs.

Culture & Benefits

• 70/30 work model emphasizing in-office collaboration, innovation, teamwork, and mentorship.
• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health resources.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs.