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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.
  • Handles change control of approved products
  • Copes with GMP / compliance inspection by PMDA
• Management of regulatory changes in Japan
  • Assesses the impact of new / revised CMC regulations and implements necessary changes
• Contribute through task force / external activities
  • Participates in task forces/initiatives, collaborating with team members, as well as global and cross functional stakeholders to achieve continuous improvement.
  • Participates in external events or industry activities and makes a positive impact.

Minimum Qualification

Experience/Knowledge

• At least 5 years’ experience in CMC related area in pharmaceutical industry
• Familiar with CMC regulatory notifications in Japan
• Experience of completing NDAs in Japan either independently as a CMC-RA representative or as a team leader or Experience in regulatory procedures in pharmaceutical research / CMC-related operations

Skills/Capabilities

• Ability to discuss CMC regulatory topics with global members in English
• Able to build trust with others including global members and government
• Able to respect others and appropriately discuss and build consensus with team members
• Adaptability to IT/DX

Qualification/Certificate

• Bachelor, Master, Doctor of Science degree

＜ 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.

• Once you move to 1st interview stage, please make sure to inform to your current manager.

• For Employee Referral Program (ERP), please read and understand the details of “Employee Referral Program” in Ask GS and make a compliant referral.

• Based on your experience and interview evaluation, the position title and level may vary.

Required Skills:

Preferred Skills: