[Innovative Medicine] R&D, Scientist/Manager, CMC Group, CMC Sciences, Regulatory Affairs Full-time

Scientist

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:

JOB SUMMARY:

• To conduct change control of approved products appropriately as CMC-regulatory affairs (CMC-RA).
• To prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval.

KEY RESPONSIBILITIES:

• Change control activities for approved drug products as CMC-RA Regulatory Affairs (chemical and biological products)
• Conduct regulatory assessment and develop regulatory strategy
• Collaborate with global and local stakeholders related to CMC-RA activity in Japan
• Prepare, review and conduct QC of the CMC part of the dossier (e.g. manufacturing process, specifications and test methods, and stability) with logical and scientific quality
• Prepare and reply to CMC questions from PMDA, and communicate directly with PMDA officials
• Conduct GMP inspection related activities
• Conduct regulatory consultations
• Conduct CRO management if the above activities are outsourced

* May be in charge of new drug application

REQUIREMENTS:

• Experience/Knowledge
• At least 3 – 5 years' experience in CMC related arena in pharmaceutical industry
• Experience in change control operations (partial change applications) for post approved products several times
• Experience in preparation of CTD and application form several times
• Experience in CMC operations for multiple products including chemical products and biological products is desirable (including continuous manufacturing, antibodies, and cell & gene therapy products)
• Experience in new drug application is also desirable
• Qualification/Certificate
• Practical level English skill (TOEIC ≥ 700)
• Bachelor, Master, Doctor