Associate Director, Global Regulatory Science, CMC

Overview

In this role, you lead CMC regulatory activities and shape international submission strategies to advance transformative mRNA medicines. You will partner with manufacturing, quality, and cross-functional teams to ensure submission readiness and robust regulatory support. The position places you at the forefront of interactions with health authorities, contributing to multiple programs and global regulatory excellence. This opportunity offers impact across diverse therapeutic areas and a chance to influence global patient access.

Pay / Benefits

• best-in-class healthcare
• family building benefits
• generous paid time off
• savings and investments
• well-being resources (fitness, mindfulness, mental health)
• location-specific perks and extras

Responsibilities

• Develop and implement CMC regulatory strategies for international submissions
• Review documents for submission-readiness per health authority guidelines
• Provide regulatory guidance to manufacturing and quality teams
• Lead regulatory CMC discussions and interactions with health authorities
• Enhance regulatory processes and procedures supporting CMC components
• Oversee multiple programs and evaluate CMC change controls and their impact
• Lead and support regulatory activities delivering high-quality CMC sections of regulatory documentation

Key requirements

• BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field
• MS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field (desirable)
• 10+ years in pharmaceutical/biotech with manufacturing and/or analytical focus
• 8+ years in Biologics focused Regulatory CMC
• Multidisciplinary focus on vaccines, oncology, and/or rare diseases
• Strong knowledge of EU and ROW regulations
• Strong knowledge of CGMP
• Strong experience with CTD format and content regulatory filings
• Exceptional written and oral communication

• exceptional written and oral communication
• cross-functional collaboration
• stakeholder management
• CMC regulatory strategy
• international submissions
• regulatory documentation (CTD)

…