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Job Description:

JOB 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.

KEY RESPONSIBILITIES:

• Attends the project team meeting and contributes product development
• Creates CMC dossiers for the filing of new drug candidates and for the partial change application of approved products
• Conducts document QC to make sure the regulatory compliance of registration dossier
• Prepares and answers to CMC questions from PMDA, and communicate directly with PMDA officials where necessary.
• Obtains and maintains accreditation of foreign manufacturing site
• Handles change control of approved products
• Copes with GMP inspection by PMDA (to audit foreign manufacturing site before J-NDA or PMDA inspection)
• Handles J-DMF registration and change control
• Maintains CMC document

REQUIREMENTS:

Experience/Knowledge

• At least 3 – 5 years’ experience in CMC related arena in pharmaceutical industry

Qualification/Certificate

• 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.