Associate Principal Scientist – Global Vaccines CMC

About the role

The Associate Principal Scientist will lead Chemistry, Manufacturing and Control (CMC) regulatory strategies for global vaccine products, ensuring compliance with worldwide regulations and supporting the development of regulatory dossiers.

Key responsibilities

• Lead global product and project regulatory strategies by identifying requirements and assessing risks.
• Develop, author and review CMC submission components for approvals, supplements and annual reports.
• Liaise with manufacturing, CMC teams and external partners to ensure compliant change management.
• Assess regulatory risks and propose mitigation strategies throughout the product lifecycle.

Required profile

• Bachelor’s degree in science, engineering or related field; advanced degree preferred.
• At least 5 years of pharmaceutical industry experience managing CMC regulatory submissions for vaccines or biologics.
• Strong oral and written communication, ability to evaluate scientific data.

Required skills

• Veeva electronic document management system.
• Electronic Common Technical Document (eCTD) preparation.
• Biologics License Application (BLA) processes.
• Regulatory CMC strategy development and writing.

What we offer

• Competitive salary range $142,400 – $224,100 per year.
• Annual bonus and long‑term incentive opportunities.
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays and vacation.