Global Regulatory CMC Lead (Biologics)

Location: Cambridge or Norwood, Massachusetts, United States; 70/30 in-office work model. Due to U.S. export control requirements, only U.S. persons are eligible.

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

Company

hirify.global develops mRNA technology, medicines, and related scientific infrastructure.

What you will do

• Develop and implement global CMC regulatory strategies for IND, CTA, BLA, and MAA submissions.
• Identify regulatory risks and guide CMC aspects of biologics product development programs.
• 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 guidance to manufacturing, quality, and process or analytical development teams.
• Develop regulatory processes, procedures, and CMC submission templates.

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 biotechnology industry, with manufacturing and/or analytical experience.
• 5+ years of experience in biologics-focused regulatory CMC.
• Strong knowledge of global CMC regulations and CTD format and content for regulatory submissions.
• Broad experience with CMC regulatory procedures and legislation covering drug development, registration, line extensions, and license maintenance.
• Ability to collaborate across a dynamic matrix, work independently, and communicate exceptionally well in writing and verbally.

Culture & Benefits

• In-person collaboration supported through a 70/30 in-office work 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 discretionary year-end shutdown.
• Savings and investment programs, plus location-specific benefits.