The role requires developing and executing regulatory strategies to achieve rapid approval and launch of cell therapy products in the assigned portfolio
Job Summary
The role requires developing and executing regulatory strategies to achieve rapid approval and launch of cell therapy products in the assigned portfolio.
Candidates must maintain detailed knowledge of product dossiers, commercial strategies, and supply strategies while ensuring compliance with local and global regulations.
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 of cell therapy products in the assigned portfolio.
Skills & Requirements
Must-have
Bachelor degree in Pharmacy or Biology
2+ years regulatory affairs experience
Deep knowledge of China regulatory landscape
Strong project management skills
Fluent English communication abilities
Nice-to-have
Experience in drug manufacturing processes
Proven track record in major pharmaceutical companies
Ability to build trust partnerships with peers
Knowledge of global regulatory policies
Experience with issue management strategies
Key Requirements
Bachelor's degree in Pharmacy, Medical, or Biology
Minimum 2 years experience in regulatory affairs
Right to work in the country where role is advertised