Associate Director, CMC Regulatory Affairs, International (Biologics)

Location: London, England; 70% in-office work under hirify.global's 70/30 model

Company

hirify.global develops mRNA medicines and operates a global biotechnology platform focused on transforming medicine.

What you will do

• Develop and implement global CMC regulatory strategies for INDs, CTAs, BLAs, MAAs, and regional applications.
• Lead preparation, review, governance, and oversight of CMC and Quality regulatory submissions and agency correspondence.
• Provide strategic regulatory guidance to Manufacturing, Technical Operations, Quality, and Development teams throughout the product lifecycle.
• Assess regulatory risks, change controls, evolving guidance, and compliance requirements affecting product development and market access.
• Lead interactions and negotiations with international health authorities across vaccines, oncology, and rare disease programs.
• Support lifecycle management and regulatory planning for biologics in international and emerging markets, especially LATAM.

Requirements

• BS in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field.
• 10+ years of experience in the pharmaceutical or biotechnology industry, manufacturing, or analytical functions.
• 8+ years of experience in biologics-focused Regulatory CMC.
• Experience in vaccines, oncology, and/or rare diseases.
• Strong knowledge of current EU and rest-of-world regulations, cGMP, and CTD filing content and format.
• Exceptional written and oral communication skills.

Nice to have

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

Culture & Benefits

• Collaborative, fast-paced, results-oriented environment with a strong emphasis on in-person collaboration.
• Healthcare coverage and voluntary benefits.
• Fitness, mindfulness, and mental health support.
• Family-building benefits, including fertility, adoption, and surrogacy support.
• Paid vacation, bank holidays, volunteer days, sabbatical, recharge days, and year-end shutdown.
• Savings and investment programs plus location-specific benefits.