Associate Principal Scientist, Global Vaccines Chemistry, Manufacturing and Control
Core
Develop and implement global Chemistry, Manufacturing and Control (CMC) regulatory strategies and prepare regulatory dossiers for pharmaceutical products.
Role type
Senior IC regulatory affairs scientist (CMC)
Builds
Regulatory submission components (eCTD, BLA, MAA) and global compliance documentation
Domain
Pharmaceutical industry, Global Vaccines, Chemistry, Manufacturing and Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory Strategy Development, Regulatory Writing, Regulatory Submissions, International Regulatory Compliance, Electronic Common Technical Document (eCTD), Biologics License Application (BLA), Pharmaceutical Process Development, Regulatory CMC, Detail-Oriented, Technical Writing
Preferred skills
Experience managing CMC submissions for small molecules/vaccines/biologics, Veeva system proficiency
Technologies
Veeva
Responsibilities
Lead global product and project regulatory strategies, Execute regulatory strategies by leading development of CMC submission components, Liaise with global CMC and external partners to support compliant change management, Assess and communicate potential regulatory risks, Deliver regulatory milestones across the product lifecycle
Seniority
Senior, hands-on IC