Hiring For Manager Senior Manager Regulatory Affairs API

Job Description:

• Responsible for regulatory submissions and lifecycle management of API products for the China market.
• Prepare, compile, review, and submit China DMF dossiers in line with NMPA regulatory requirements.
• Handle new registrations, amendments, renewals, and annual maintenance of regulatory filings.
• Review technical documents including CTD modules, manufacturing process, specifications, analytical methods, validation reports, impurity data, and stability reports.
• Coordinate with R&D, QA, QC, Production, and Manufacturing teams to obtain and verify submission documents.
• Draft and submit responses to regulatory deficiencies, customer queries, and authority observations within timelines.
• Track changes in China regulatory guidelines and ensure timely implementation across all registered products.
• Liaise with Chinese agents, customers, and regulatory authorities to facilitate approvals and resolve regulatory issues.
• Maintain regulatory databases, submission trackers, and ensure compliance with internal and external audit requirements.
• Support business development by providing regulatory assessments for new API products and market expansion opportunities.