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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
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

< For Internal Applicants>

• If you are Japan employee, please read "Internal Application Guideline" in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan's employee, you are not able to apply for multiple positions at once.
• For Employee Referral Program (ERP), please read and understand the details of the "Employee Referral Program (ERP)" on the AskGS and you have made a compliant referral.

Required Skills
Preferred Skills:
Analytical Reasoning, Coaching, Communication, Data Reporting, Drug Discovery Development, Execution Focus, Healthcare Trends, Process Oriented, Public Policies, Regulatory Compliance, Regulatory Development, Regulatory Reporting, Relationship Building, Risk Compliance, Scientific Research, Technical Writing, Technologically Savvy