Not specified (assumed hybrid based on industry norms).
Author regulatory submission documents
Conduct formal review of authored documents
Manage regulatory writing activities for local submissions
Amgen UK is seeking a Global Regulatory Writing Manager for its Japan operations, responsible for preparing scientific and regulatory submission documents while maintaining relationships with cross-functional teams. The ideal candidate should have significant experience in regulatory writing within the biotech or pharmaceutical industry and possess strong communication skills in both Japanese and English
Job Summary
The role involves preparing and gaining approval for scientific and regulatory submission documents that comply with global and local standards.
Incumbents will author key documents such as Clinical Overviews, eCTD Module 2 summaries, and Briefing Documents while managing cross-functional relationships.
This position may serve as a functional area lead on product teams, providing input on regulatory plans and mentoring junior writers.
Matching Summary
Match Score: 85
Amgen UK is seeking a Global Regulatory Writing Manager for its Japan operations, responsible for preparing scientific and regulatory submission documents while maintaining relationships with cross-functional teams. The ideal candidate should have significant experience in regulatory writing within the biotech or pharmaceutical industry and possess strong communication skills in both Japanese and English.
Skills & Requirements
Must-have
Author regulatory submission documents
Conduct formal review of authored documents
Manage regulatory writing activities for local submissions
Serve as functional area lead on product teams
Analyze scientific data with limited oversight
Excellent written communication in local native language
Nice-to-have
Train and mentor junior writers
Work with CRO and freelance writers
Generate document timelines with team input
Demonstrate leadership through negotiation and collaboration
Self-starter with drive to achieve results
Key Requirements
Doctorate degree OR Master's degree with 3 years experience
Bachelor's degree with 5 years directly related experience
5+ years experience in medical writing within Biotech/Pharma