The role requires developing and executing regulatory strategies to achieve rapid approval and launch for an oncology portfolio
Job Summary
The role requires developing and executing regulatory strategies to achieve rapid approval and launch for an oncology portfolio.
Candidates must maintain detailed knowledge of commercial strategies, dossier content, and regulatory timelines while ensuring local compliance with global policies.
The position involves actively building relationships with local regulatory authorities and influencing external stakeholders to improve regulatory outcomes.
Matching Summary
The role requires developing and executing regulatory strategies to achieve rapid approval and launch for an oncology portfolio.
Skills & Requirements
Must-have
Bachelor degree in Pharmacy or Biology
2+ years pharmaceutical regulatory experience
Deep knowledge of China NMPA regulations
Strong stakeholder relationship management
Fluent English communication skills
Nice-to-have
Experience in drug manufacturing processes
Proven track record of successful approvals
Team management and mentorship capabilities
Ability to work with urgency and priority
Key Requirements
Bachelor's degree in Pharmacy, Medical, or Biology
Minimum 2 years experience in pharmaceutical regulatory affairs