Associate Director, CMC Regulatory Science, International (mRNA)

Location: London, England; based at the Harwell, UK site with a 70/30 in-office work model.

Company

hirify.global develops mRNA technology and medicines, with a focus on transforming how medicines are created and delivered.

What you will do

• Develop and implement CMC regulatory strategies for global IND, CTA, BLA, and MAA submissions while identifying regulatory risks.
• Provide CMC regulatory guidance across product development, manufacturing, quality, process development, and analytical development programs.
• Review submission documentation for readiness and alignment with health authority guidelines.
• Lead CMC discussions and interactions with health authorities to facilitate submission review and approval.
• Develop regulatory processes, procedures, and templates supporting CMC submissions.
• Oversee multiple programs across vaccines, oncology, and rare diseases, including evaluation of CMC change controls.

Requirements

• MS or PhD in Molecular Biology, 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.
• Strong knowledge of current EU and rest-of-world regulations and cGMP.
• Strong experience with CTD format and regulatory filing content.
• Ability to work at the Harwell, UK site under a 70/30 in-office model.

Culture & Benefits

• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family-building benefits, including fertility, adoption, and surrogacy support.
• Paid time off including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a year-end shutdown.
• Savings and investment programs, plus location-specific benefits.
• In-person collaboration, mentorship, and a workplace culture centered on scientific progress and patient impact.