All jobs
J&
[Innovative Medicine] R＆D, Scientist, CMC Group, CMC Sciences, Regulatory Affairs
Johnson & Johnson
hybrid
Chiyoda, Tokyo, Japan
About this role
[Innovative Medicine] R＆D, Scientist, CMC Group, CMC Sciences, Regulatory Affairs
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
Read the full description on TalentApply
Create a free account to see the complete job description, how well your CV matches this role, and apply in one click.
Clean up your CV
AI rewrites and formats your CV so it reads well and gets past screeners.
See how you score
Get your match percentage for this exact role before you spend time applying.
Apply professionally
Send a polished application in one click — no retyping the same details.
Track it easily
Follow every application in one place instead of digging through your inbox.
Free account · No card required
Your next opportunity starts here
Prepare, apply, track, interview and get hired — all from one platform, with AI in your corner.