Gina Chang

• Plan and prepare regulatory submissions for new medical devices and product changes for Taiwan, Hong Kong, China. • Developed regulatory strategies, obtained and maintained product approval, and served as a communication liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office. • Maintained registration information and obtain re-registration approvals in advance of license expiration to ensure no disruption in product availability.

• Evaluated early-stage products and initiated new drug registration strategies including small molecular, biologics, and orphan drugs. • Prepared and submitted 7 New Drug Applications including diabetes, lipid-lowering, immune disease products. • Created dossiers followed ICH E5 - bridge study evaluation (BSE) - for 4 new drugs. • Adhered to project deadlines, through proactive communication with TFDA and efficient time management.

• Analyzed drug market & built value position to establish new drug Value Dossier for reimbursement application. • Prepared high-quality Value Dossier and achieved reimbursement price for Zentiva project products. • Estimated drug reimbursement price cut impact and provided results to the marketing and financial department by analyzing health authority pharmaceutical data and regulations.

• Managed drug licenses for 30+ drugs, ensuring leaflets and artwork were compiled in compliance with company and local health authority branding requirements.

Mailman consulting group for Ronald McDonald House New York

Certified Pharmacist, Taiwan, license number 035553