- 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 perform in scope activities.
- Authoring of high-quality variation packages for "partial change application (PCA)” and minor change notification.
- Authoring response to RTQ (request to query)'s based on the guidance from the CMC strategist in-line with current Japan requirements.
- Operational support for Authoring of packages for GMP inspection [PAI for NDA and PCA/Periodic]
- Operational support for Authoring of packages for GMP inspection - Foreign Manufacturer Accreditation for PMDA consultation.
- Liaise with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
Benefits
- Work Style: Remote flexibility
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