Associate Principal Scientist, Global Vaccines Chemistry, Manufacturing and Control

Role: Lead global regulatory strategies for pharmaceutical products, focusing on Chemistry, Manufacturing, and Controls (CMC) for both development and commercial stages. Responsibilities: oversee the development, review, and submission of regulatory documentation such as CTDs, Drug Master Files, NDAs, BLAs, and variations; liaise with internal manufacturing teams and external partners including CMOs to ensure compliance; assess regulatory risks and devise mitigation strategies; deliver regulatory milestones across product lifecycle. Requirements: Bachelor's in science, engineering, or related field; 5+ years in pharma regulatory affairs with experience managing CMC submissions for small molecules, biologics, or vaccines; proficiency in electronic systems like Veeva; strong communication and technical writing skills. Preferred: advanced degree, experience with global regulatory pathways, and familiarity with eCTD. High-value specifics: focus on biologics, vaccines, or small molecules; involvement in development and post-approval phases; emphasis on global regulatory compliance, change management, and risk assessment. Collaboration: cross-functional engagement with manufacturing, quality, and external partners; reporting to senior regulatory leadership. Work setup: hybrid, US-based with no travel required.