Johnson & Johnson is seeking an Asia Pacific Regulatory Affairs Manager to lead and implement regional regulatory strategies for assigned oncology products. The role involves collaboration with local regulatory teams and global counterparts, ensuring compliance and facilitating successful product registrations across multiple AP countries
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 ensures timely responses to Health Authority inquiries and provides general regulatory support to affiliates in the region.
The position requires understanding regional and local requirements and advising Global Regulatory Teams on applicable regulatory processes.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking an Asia Pacific Regulatory Affairs Manager to lead and implement regional regulatory strategies for assigned oncology products. The role involves collaboration with local regulatory teams and global counterparts, ensuring compliance and facilitating successful product registrations across multiple AP countries.
Skills & Requirements
Must-have
Define and implement regional strategy
Lead regulatory strategic input
Manage product variations and labeling changes
Respond to Health Authority inquiries
Track changes in regulatory requirements
Prepare for health authority meetings
Nice-to-have
Proactive team player
Achievement-oriented
High degree of flexibility
Cultural sensitivity
Work in a matrix environment
Key Requirements
Bachelor’s degree 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
Proficiency in English and Mandarin/Asian languages preferred