【Alexion Japan】Senior (Labeling) Manager Regulatory
American Association of Physicists in Medicine(1 month ago)
About this role
A Senior Manager, Regulatory Affairs focused on Japanese pharmaceutical labeling, ensuring JPIs and related documents meet local regulatory requirements and align with global standards. The role serves as the company's Japanese labeling specialist and primary contact for interactions with Japanese regulatory authorities to support product lifecycle management.
Required Skills
- Japanese Labeling
- JPI Creation
- Label Revisions
- Patient Guides
- Promotional Review
- Translation Management
- Regulatory Liaison
- Stakeholder Coordination
- Vendor Negotiation
- PMDA Management
+3 more
Qualifications
- BA/BS in Life Sciences
About American Association of Physicists in Medicine
aapm.orgN/A
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