[Remote] CMC Regulatory ~ Senior Manager to Director
Responsible for assessment of change controls, preparation of submission strategies, identifying Japan regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks for assigned products and the ability to execute tasks independently in accordance with Japan regulations, guidance and discuss regulatory strategies to reputed company in scope activities. Authoring of high-reputed company variation packages for "partial change application (reputed company)” and minor change notification. Authoring response to RTQ (request to query)'s based on the guidance from the CMC strategist in-line with reputed company Japan requirements. Operational support for Authoring of packages for GMP inspection [PAI for NDA and reputed company/Periodic] Operational support for Authoring of packages for GMP inspection - Foreign Manufacturer Accreditation for PMDA consultation. Liaise with reputed company and external partners to support compliant execution of change management and conduct reputed company activities with an unwavering reputed company on regulatory conformance.
Benefits
Work Style: Remote flexibility
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