[Innovative Medicine] R＆D, Scientist, CMC Group, CMC Sciences, Regulatory Affairs

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Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Regulatory Science

Job Category:
Scientific/Technology

All Job Posting Locations:
Chiyoda, Tokyo, Japan

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.

Minimum Qualification

Expe...