Associate Director, CMC Regulatory Affairs, International (Biologics)

Location: London, England, United Kingdom. The role follows hirify.global's 70/30 work model, with 70% of work conducted in the office.

Company

hirify.global develops mRNA medicines and operates a technology platform focused on transforming how medicines are created and delivered.

What you will do

• Develop and implement global CMC regulatory strategies for international submissions, including INDs, CTAs, BLAs, MAAs, and regional applications.
• Lead preparation, review, and oversight of CMC and Quality-related agency correspondence and regulatory submissions.
• Govern CMC submission activities, assess regulatory risks, and support product development, market access, and lifecycle management.
• Provide strategic CMC regulatory guidance to Manufacturing, Technical Operations, Quality, and Development teams.
• Lead discussions and negotiations with international health authorities and oversee programs across vaccines, oncology, and rare disease.
• Improve CMC submission processes, templates, regulatory intelligence, data management, and submission planning using digital and AI-enabled capabilities.

Requirements

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

Nice to have

• MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field.
• Experience with regulatory planning and execution in emerging markets, particularly LATAM.

Culture & Benefits

• In-person collaboration model designed to support innovation, teamwork, and direct mentorship.
• Healthcare and voluntary benefits, with offerings varying by employment terms and country.
• Fitness, mindfulness, and mental health resources.
• Family-building support, including fertility, adoption, and surrogacy benefits.
• Paid vacation, bank holidays, volunteer days, sabbatical, recharge days, and year-end shutdown.
• Savings and investment programs plus location-specific perks.