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Job Details

Location
Japan
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-18968
Contact
Yin Yin Pui
Contact email
Email Yin
Contact phone
+65 6692 0751
Posted
5 months ago
Location: Osaka / Tokyo, Japan
Industry: Pharmaceutical


Responsibilities:

  • Engaged with PMDA and Japanese Ministry of Health officials, securing crucial approvals through effective communication.
  • Optimized regulatory assessment processes for compliance, expediting product development timelines.
  • Cultivated strong relationships with Global PRA teams across Europe and Asia, fostering seamless collaboration.
  • Provided expert guidance on Japanese pharmaceutical requirements, bridging international gaps for alignment.
  • Directed creation of essential pharmaceutical materials, ensuring a smooth regulatory submission process, and oversaw the entire lifecycle of new drug applications, facilitating successful market entry.


Requirements:

  • Academic background with a scientific degree
  • Previous experience leading pharmaceutical affairs development, including interactions with regulatory authorities essential
  • Practical experience in negotiations and effective communication with regulatory bodies mandatory
  • Proficiency in Business-level English, both in communication and document writing is essential
  • Experience in global clinical trials advantageous



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