Associate Director, Global Regulatory Science, CMC (mRNA)

Location: London, England, with a 70/30 work model requiring regular in-office presence

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 across an mRNA development portfolio.
• Lead CMC regulatory activities throughout product development and prepare, review, and deliver compliant CTD submission sections.
• Provide expert regulatory guidance to Manufacturing, Quality, and cross-functional development teams.
• Lead CMC regulatory discussions and represent Regulatory Affairs in interactions with global health authorities.
• Oversee multiple global development programs, including evaluation of CMC change controls and their regulatory impact.
• Improve regulatory processes, procedures, templates, document quality, and operational efficiency using advanced digital capabilities and Generative AI tools.

Requirements

• BS in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field.
• 10+ years of experience in the pharmaceutical or biotech industry, manufacturing, and/or analytical functions.
• 8+ years of experience in biologics-focused Regulatory CMC.
• Experience across therapeutic areas such as vaccines, oncology, and/or rare diseases.
• Strong knowledge of current EU and rest-of-world regulations, cGMP, and CTD filing requirements.
• Exceptional written and oral communication; an enhanced pre-employment check may be required.

Nice to have

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

Culture & Benefits

• In-person collaboration supported by a 70/30 in-office work model.
• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health resources.
• Family-building support, including fertility, adoption, and surrogacy benefits.
• Paid time off including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs, plus location-specific perks.