Associate Director, CMC Regulatory Science, International

Overview

In this role you will lead CMC regulatory strategy and oversight for global submissions, supporting mRNA product development. You’ll guide regulatory CMC activities across development teams and interact with health authorities to advance submissions. You will also help establish CMC processes, templates and governance to enable timely, compliant regulatory deliverables. This role offers exposure to multiple therapeutic areas and a fast-paced, high-growth environment.

Pay / Benefits

• Best-in-class healthcare
• Family building benefits (fertility, adoption, surrogacy)
• Generous paid time off and holidays
• Sabbatical and global recharge days
• Savings and investments
• Location-specific perks and extras

Responsibilities

• Develop/implement global CMC regulatory strategies for submissions (IND/CTA/BLA/MAA) and identify risks
• Guide regulatory CMC aspects of product development projects
• Review submission-readiness documents to ensure guideline conformance
• Lead CMC discussions and interactions with health authorities
• Develop regulatory processes and procedures to support CMC submissions
• Create and maintain CMC submission templates
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls
• Interpret regulatory guidance documents and advise internal teams on applicability/impact
• Oversee multiple programs across vaccines, oncology and/or rare diseases

Key requirements

• MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field
• 10+ years in the pharmaceutical/biotech industry (manufacturing and/or analytical)
• 8+ years of Biologics-focused Regulatory CMC experience
• Enhanced pre-employment check may be required

• Exceptional written and oral communication
• Strong collaboration and cross-functional influence
• Ability to manage multiple projects in a fast-paced environment
• Strong knowledge of EU and ROW regulations
• Solid understanding of cGMP
• Experience with CTD format and content regulatory filings

…