Associate Director, Global Regulatory, CMC

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

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

Company

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

What you will do

• Develop and implement global CMC regulatory strategies for IND, CTA, BLA, and MAA submissions.
• Coordinate regulatory CMC activities across products and stages of the product lifecycle.
• Identify regulatory risks and provide guidance on CMC aspects of 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 guide manufacturing, quality, process development, and analytical development teams.

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 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 for regulatory submissions.
• Broad experience with CMC regulatory procedures and legislation covering drug development, product registration, line extensions, and license maintenance.
• Ability to work independently and collaborate effectively in a dynamic cross-functional matrix environment.

Culture & Benefits

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