of Job Description: Deliver the qualified drug timely to the patients by contributing to the regulatory approval of the new drug as the CMC... responsibility person and updating regulatory commitments of the marketed products according to CMC variations. Major...
and operational excellence. Reporting Relationships: This role reports to: Regulatory CMC Group Manager, Regulatory Affairs, R... pharmaceutical industry experience in CMC, either in RA and/or QA etc. At least 3 years of Regulatory CMC experience for development...
一緒に働きましょう。 Responsibilities will include, but are not limited to; Make a strategic J-NDA plan for RA CMC and execute; Deeply understand CMC... analysis. Plan & execute CMC-related CTD preparation collaborating with QA and RA colleagues to keep J-NDA timeline. Decide...
affairs (RA) activities from the development to the life cycle management, with collaborative with global and Japan... stakeholders. Regulatory Affairs Senior Manager focuses on some of the following activities in Regulatory Affairs Group 1 or Group...