Associate Director, CMC Regulatory Science, International (mRNA)

Location: Based at the Harwell, UK site; hirify.global follows a 70/30 work model with 70% in-office collaboration.

Company

hirify.global develops an mRNA technology platform and medicines intended to transform how treatments are created and delivered.

What you will do

• Develop and implement CMC regulatory strategies for global IND, CTA, BLA, and MAA submissions.
• Prepare and oversee CMC and Quality agency correspondence and regulatory applications for mRNA products.
• Review regulatory documents for submission readiness and alignment with health authority guidelines.
• Lead CMC discussions with health authorities to facilitate submission review and approval.
• Provide regulatory guidance to Manufacturing, Quality, and Process and Analytical Development teams, including evaluation of CMC change controls.
• Oversee multiple programs across vaccines, oncology, and rare diseases.

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.
• Exceptional written and oral communication skills.

Nice to have

• Multidisciplinary experience in vaccines, oncology, and/or rare diseases.

Culture & Benefits

• Healthcare coverage and voluntary benefits programs.
• Fitness, mindfulness, and mental health support.
• Family-building benefits, including fertility, adoption, and surrogacy support.
• Paid vacation, bank holidays, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment programs, plus location-specific perks.