Manage multiple brands/compounds to obtain regulatory approval for development, manufacturing, sales, and marketing activities
Job Summary
Manage multiple brands/compounds to obtain regulatory approval for development, manufacturing, sales, and marketing activities.
Develop and implement strategic regulatory direction for the China portfolio to achieve timely and high-quality approvals and facilitate full-speed launch.
Supervise, coach, and support junior staff to achieve RA goals and encourage best practices.
Matching Summary
Manage multiple brands/compounds to obtain regulatory approval for development, manufacturing, sales, and marketing activities.
Skills & Requirements
Must-have
regulatory approval strategy
lifecycle management
stakeholder management
regulatory environment assessment
policy interpretation and advocacy
Nice-to-have
building trustful relationships
challenging status quo
open and trusting atmosphere
keen sense of urgency
Key Requirements
Minimum 12 years in regulatory affairs
Minimum 2 years in specific positions
Experience handling complex regulatory projects
Experience in complex regulatory environment assessment
Experience in crisis management
Bachelor degree or above in Pharmacy, Medical, Biology