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Johnson & Johnson is seeking an APAC Regulatory Affairs Manager to lead regional regulatory strategies for assigned products in the oncology therapeutic area. The role requires collaboration with local and global teams, ensuring compliance with regional regulatory requirements while providing strategic input for successful product registrations.
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Job Summary
The Regional Regulatory Manager Asia Pacific is responsible for defining and implementing the regional strategy for assigned products, providing regulatory strategic input, and ensuring successful regulatory filings.
This role involves managing regulatory interactions with local operating companies and regional functions, serving as a point of contact, and ensuring collaborative relationships with key stakeholders.
The position requires hands-on experience in pharmaceutical product registration in AP countries, familiarity with AP regulatory systems, and the ability to handle multiple projects while communicating effectively to senior management.
Matching Summary
Match Score: 75
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Johnson & Johnson is seeking an APAC Regulatory Affairs Manager to lead regional regulatory strategies for assigned products in the oncology therapeutic area. The role requires collaboration with local and global teams, ensuring compliance with regional regulatory requirements while providing strategic input for successful product registrations.
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Skills & Requirements
Must-have
APAC regulatory strategy
product registration in AP countries
health authority interactions
regulatory submissions
lifecycle management
Nice-to-have
cultural sensitivity
proactive team player
achievement-oriented
flexibility and adaptability
Key Requirements
Minimum 8+ years of overall experience (5+ years relevant pharmaceutical industry and regulatory experience)
Bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline
Hands-on experience in pharmaceutical product registration in AP countries
Familiarity with AP regulatory systems and product registration requirements
Previous experience in preparing documents for health authority submissions