Job Description:
Position Summary
To prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval.

To conduct change control of approved products appropriately.



Specific Tasks and Job Duties

・Manage Team management
Fulfill CMC-RA responsibilities at team meetings and contribute to compound development / product lifecycle management
Supervises members, manage resources and timelines to deliver activities on schedule.

・CMC-RA strategy planning / alignment
Identifies and inputs relevant Japan CMC regulatory information required to develop global CMC-RA strategy at the project initiation.
Develop Japan CMC-RA NDA strategy
Align to the product’s global post-marketing regulatory strategy.

・CMC dossier management
Creates pre- / post- approval CMC dossiers including consultation documents.
Ensure regulatory document compliance through appropriate document preparation including accurate writing, review, QC, and compliance checks.
Reviews CMC documents prepared by team members and provides valuable input.

・Implement regulatory procedures
Prepares and answers to CMC questions from PMDA, and communicate directly with PMDA officials where necessary.
Handles change control of approved products
Copes with GMP / compliance inspection by PMDA

・Management of regulatory changes in Japan
Assesses the impact of new / revised CMC regulations and implements necessary changes

・Contribute through task force / external activities
Participates in task forces/initiatives, collaborating with team members, as well as global and cross functional stakeholders to achieve continuous improvement.
Participates in external events or industry activities and makes a positive impact.