Associate Principal Scientist, Global Vaccines Chemistry, Manufacturing and Control

Role: Lead global regulatory strategies for Chemistry, Manufacturing, and Control (CMC) sections of pharmaceutical products, ensuring compliance with international regulations and supporting product approvals. Responsibilities: develop, author, and review regulatory submissions such as NDAs, BLAs, and variations; liaise with manufacturing partners, assess regulatory risks, and deliver milestones across product lifecycle. Qualifications: Bachelor's in science or engineering; 5+ years in pharma regulatory affairs, with experience in CMC, biologics, or vaccines; proficiency in electronic submission systems like Veeva; strong communication, technical review, and leadership skills. High-Value: expertise in biologics, vaccines, or small molecules; regulatory submissions including BLA/MAA; experience with global regulatory requirements; focus on CMC development, change management, and cross-functional collaboration. WorkSetup: hybrid, no travel required.