Regulatory Affairs Supervisor
Core
Manage registration of new products and variations to obtain and maintain marketing approvals for AbbVie products in Taiwan, ensuring compliance with local regulations and supporting clinical research and product launches.
Role type
Regulatory Affairs Supervisor
Builds
Marketing approvals for pharmaceutical products in Taiwan
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
New drug application (NDA) preparation, regulatory submission management, deficiency letter response, government agency liaison, product labeling review, regulatory change impact assessment, SOP maintenance
Preferred skills
Strategic thinking, analytical thinking, cross-functional communication
Technologies
None stated
Responsibilities
Manage registration of new products and variations; Coordinate responses to deficiency letters; Liaise with government officials; Update product labeling; Generate registration plans; Report progress to management; Evaluate regulatory impact on business; Maintain knowledge of local regulations; Update RA SOPs.
Seniority
Mid-level, hands-on IC
