The role directs the development of product registration submissions and provides strategic direction to teams on interacting with regulatory agencies
Job Summary
The role directs the development of product registration submissions and provides strategic direction to teams on interacting with regulatory agencies.
The incumbent is responsible for implementing global regulatory strategies across assigned regions to ensure timely approvals and maintain compliant status.
This position requires facilitating timely responses to Health Authority requests and leading negotiations for regional drug and device approvals.
Matching Summary
The role directs the development of product registration submissions and provides strategic direction to teams on interacting with regulatory agencies.
Skills & Requirements
Must-have
Regulatory strategy implementation
Health Authority interactions
Dossier submission management
Clinical trial application review
Risk management plan development
Nice-to-have
Cross-cultural experience
Negotiation skills with agencies
Project management expertise
Detail-oriented approach
Global regulatory knowledge
Key Requirements
Functional breadth in operations management
Experience with clinical trials and drug development