Position Purpose

Achieve successful filing and approval of the following CMC dossiers in Japan with sophisticated CMC regulatory strategies.

• NDA for NCE (New Chemical Entities)
• Life cycle management of NCE
• Post-approval change management of NCE

• Fostering and actively developing talents
• Build up and maintain cooperative relations with following relevant stakeholders: Global CMC, GRS, PharmSci, PGS, CQSA and Development Japan
• Exercise and maintain engagements/relationships with regulatory authorities
• Set department objectives with middle-term objectives and manage multiple projects/non-project activities
• Ensure timelines and quality of all tasks in the department
• Prioritize tasks and allocate staff appropriately/flexibly in the department
• Supervise/advise staff to achieve individual and department objectives
• Manage budget and budget for the coming year
• Find out common issues in the department and provide/execute best countermeasures

• Demonstrate leadership & ability to engage disciplines at cross-functional level
• Self-motivated in developing technical/regulatory leadership
• Focus on balancing business needs with regulatory expectations
• Driven to identify innovative & effective opportunities to expedite regulatory approvals

• Applied knowledge of CMC discipline in Pharmaceutical industry
• Negotiation skills with internal/external stakeholders
• Familiarity with regional regulatory requirements in CMC discipline and interpret these into business objectives

• Applied experience in developing & preparing regulatory submissions
• 10 years of experience in CMC discipline in Pharmaceutical industry
• 5 years of experience in people management (not essential)

• Bachelor's degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) and/or technical discipline
• TOEIC score of 730 or higher