• Strategic planning of BSE and NDA based on accelerated pathways. • Experience in agency consultation.• Planning for indication filings of various therapeutic areas.• Coordination of all indications for immuno-oncology product, including timelines, artwork implementations, and post-marketing commitments.

• Chaired new drug applications and accelerated artwork development to bring importation forward.• Accelerated approval of new indications for immuno-oncology product.• Formalized detailed requirements and strategies for NDAs of NCE and biologics. Delivered to regional team to establish country sheet.• Ensured completion of post-approval changes of 17 products without any stock-out issue.• Country Subject Matter Expert for artwork system and SOP training system.• Responded to product quality complaints notified by TFDA.

Ensured timely approval of post-approval variations for women health, anti-inflammatory, and musculoskeletal products, etc. These include new posology, site registrations, source changes, labeling updates, CMC updates, etc. Coordinated artwork implementation activities.

Coordinated product manufacture and registration process with customers, suppliers, and/or contract manufacture organizations. Thoroughly reviewed and checked dossiers against ICH guidelines.

Ensured compliance with cGMP, GLP and other regulatory requirements based on formal written, detailed SOPs and stringent quality assurance practices. These include performing audits of data, facilities and records, IQ/OQ/PQ documentation, etc.

• Assisted with experiments investigating calorie restriction and aging from insight of yeast.• Performed proper laboratory skills by following trained protocols involving transformation, electrophoresis, PCR, serial dilution, isolation, viable counts, and growth medium preparation.• Oversaw distribution of lab supplies and equipment.

Assist X-ray technicians with film development, portable X-ray machine, and patient transport.

Register and Assistant services at the front desk of OBS&GYN echo examination room.

Analyze and report sage-grouse behaviors in the videos derived from field studies.