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Johnson & Johnson is seeking an experienced Regulatory Affairs Manager for the Asia Pacific region, responsible for leading regional regulatory strategies for pharmaceutical products, particularly in oncology. The ideal candidate will possess extensive knowledge of local regulatory requirements and strong communication skills to interact with health authorities and internal teams.
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Job Summary
The role is responsible for defining and implementing regional regulatory strategies for assigned products within the Asia Pacific oncology sector.
Candidates must possess hands-on experience preparing documents for health authority submissions including Clinical Trial Applications and Registration dossiers.
The position requires managing interactions with local operating companies, global R&D partners, and health authorities to ensure successful product registration.
Matching Summary
Match Score: 75
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Johnson & Johnson is seeking an experienced Regulatory Affairs Manager for the Asia Pacific region, responsible for leading regional regulatory strategies for pharmaceutical products, particularly in oncology. The ideal candidate will possess extensive knowledge of local regulatory requirements and strong communication skills to interact with health authorities and internal teams.
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Skills & Requirements
Must-have
8+ years pharmaceutical regulatory experience
Oncology therapeutic area expertise
AP region regulatory submission management
Health authority interaction and negotiation
Global regulatory strategy implementation
Nice-to-have
Mandarin or Asian language proficiency
Matrix environment collaboration skills
Cultural sensitivity in multi-country teams
Strategic thinking for lifecycle management
Experience with product licensing agreements
Key Requirements
Bachelor's degree in pharmacy or life sciences
Minimum 8 years relevant industry experience
Hands-on experience in AP country registrations
Proficiency in English and preferred Asian languages