Associate Principal Scientist, Global Vaccines Chemistry, Manufacturing and Control

In this role you will lead global regulatory strategies for assigned pharmaceutical products, shaping Chemistry, Manufacturing and Control (CMC) submissions and lifecycle activities. You will work with cross-functional teams and external partners to ensure regulatory conformance and timely milestones. The role offers impact across product development and lifecycle management, contributing to global medical advancement. You will apply scientific judgment, communication skills, and regulatory expertise to navigate complex submissions and health authority questions.

• annual bonus
• long-term incentive (LTI)
• medical, dental, vision insurance
• retirement benefits including 401(k)
• paid holidays
• vacation and sick days

• Lead global regulatory strategies by identifying requirements and assessing risks
• Develop and review CMC submission components for regulatory approvals and variations
• Coordinate with Manufacturing, CMOs, and external partners to ensure compliant change management
• Assess regulatory risks and propose mitigation
• Deliver regulatory milestones across product lifecycle

• Bachelor's in science, engineering, or related field; advanced degree preferred
• 5+ years pharmaceutical industry experience or up to 3 years managing CMC regulatory submissions for small molecules/vaccines/biologics
• Experience with Veeva and electronic document GMP systems
• Strong ability to review scientific information and justify conclusions with data
• Excellent oral and written communication; ability to communicate issues clearly
• Understanding of manufacturing, analytical testing, and quality assurance

• Adaptability
• Cross-Cultural Awareness
• Detail-Oriented
• eCTD
• BLA
• Regulatory Submissions