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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

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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.