Role Overview: Assistant Manager, Regulatory Affairs (Global CMC) Position Type: Full-time Location: Dublin..., Ireland, Hyrbid. Core Responsibilities CMC Submissions: Author and coordinate CMC components for new registrations, post...
of method development of identity and purity assays Ideally experience in leading CMC studies for biopharmaceutical products...
is responsible for ensuring Eli Lilly and Company develops and executes effective post‑approval CMC regulatory strategies across its... and submissions globally. To accomplish this, the scientist develops collegial and mutually productive relationships with CMC...
years relevant pharmaceutical/biopharmaceutical experience in CMC process development and/or GMP manufacturing. Experience...
development and commercialisation, including CMC (Chemistry, Manufacturing & Controls) considerations. Ability to analyse... program goals. Understand connectivity across clinical development, CMC, and supply chain to enable successful product launch...
, Mechanical) related field is desirable. Experience of authoring CMC sections of regulatory submissions Previous leadership...