Regulatory Affairs Supervisor
Core
Manage preparation of regulatory submissions to obtain and maintain marketing approvals for new drugs and product variations in Taiwan.
Role type
Regulatory Affairs Supervisor (New Drug Applications)
Builds
Regulatory submissions and product registrations for NCEs
Domain
Pharmaceuticals (Immunology, Oncology, Neuroscience)
Required skills
Regulatory submission preparation, Deficiency letter response, Government agency liaison, Product labeling compliance, Registration plan generation, Regulatory change impact analysis, SOP maintenance, Process streamlining
Preferred skills
Strategic thinking, Analytical thinking, Interpersonal skills
Responsibilities
Manage registration of new products and variations, Coordinate responses to deficiency letters, Liaise with government officials, Review labeling for compliance, Generate registration plans, Update RA SOPs, Report progress to management
Seniority
Mid-level, hands-on IC