in leading internal audits/self-inspections. – Familiarity with regulatory submissions and CMC (Chemistry, Manufacturing...
of the CMC sections of regulatory submissions. Provide support in the evaluation of Temperature excursions for IMP...
, structure & coordinate the CMC projects portfolio in line with the Assets & Patient Supply strategic plans for (a) given... compound(s), managing the inter-connections across projects, ensure coordinated plannings & deliverables, the CMC resource...
and CMC Development/CTS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations...
to the complainant are professionally coordinated and managed. If needed work with the Vendor team and CMC Quality Lead...
interviews, process mapping, and current state assessments across CMC Dev laboratories to translate & align needs into clear... trails, etc. ELN structured data structuration: Configure data mapping according to CMC data models ensuring data/metadata...
impact the quality of the CMC sections of regulatory submissions. Provide support in the evaluation of Temperature...
CMC regulatory submissions and regulatory briefing documents and response to questions from authorities;Provide support...
). Liaise with relevant partner organizations, such as QA, chemical production, R&D, CMC RA and build a network of contacts... CMC (R&D, MSaT, industrialization) Experience in late-stage development and API industrialization Experience...
regulatory CMC compliance of plant processes with regulatory filings Contribute to compliant and right first-time product...