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Johnson & Johnson MedTech is seeking an APAC Regulatory Affairs Manager to lead regulatory strategies for oncology products across the Asia Pacific region. The ideal candidate will have extensive experience in regulatory affairs and pharmaceutical product registration, particularly in the oncology therapeutic area.
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Job Summary
The Regional Regulatory Manager Asia Pacific is responsible for defining and implementing the regional strategy for assigned products within the oncology therapeutic area.
This role involves leading regulatory strategic input, ensuring successful regulatory filings, and managing product variations and health authority inquiries.
Key responsibilities include developing regional regulatory strategies, managing health authority interactions, and ensuring timely and compliant regulatory submissions.
Matching Summary
Match Score: 75
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Johnson & Johnson MedTech is seeking an APAC Regulatory Affairs Manager to lead regulatory strategies for oncology products across the Asia Pacific region. The ideal candidate will have extensive experience in regulatory affairs and pharmaceutical product registration, particularly in the oncology therapeutic area.
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Skills & Requirements
Must-have
Regional regulatory strategy implementation
Health authority interactions
Product registration and lifecycle management
Regulatory intelligence gathering
Oncology therapeutic area expertise
Nice-to-have
Cultural sensitivity and matrix environment
Proactive team player
Flexibility and adaptability
Key Requirements
Bachelor's degree or equivalent in pharmacy or life-science
8+ years of overall experience (5+ years relevant pharmaceutical industry and regulatory experience)
Hands-on experience in pharmaceutical product registration in AP countries
Familiarity with AP regulatory systems and product registration requirements