May Wu Email & Phone Number

Taipei City, Taiwan

Responsible for biological products including QA role.Achievement:  Two new product approvals & three new PMF approvals  Two approvals of new indication variations  One approval for variation of new dosage and administration  Maintenance for 24 product licenses & 8 GMP approvals Key skill and responsibility: Ensure new product registrations, license renewals and variation applications would be approved within timeframe to be in line with company’s objectives and local regulations.  Make sure GMP registrations including PMF applications and onsite inspections as well as maintenances would be well-managed and complied with company’s policies. Support local business activities (e.g., hospital listing) from a regulatory perspective and ensure early assess of new products. Arrange packaging materials for product launch and labeling of on-market products. Timely keep the up to date regulations and properly maintain company’s database. Ensure products are released on time and meet all regulatory requirements as well as internal SOPs.  Deal with product complaints and change management. Participate company’s routine audits for plasma centers, distributors and self-audit.

Taipei City, Taiwan

Achievement:  6 new product approvals & 2 PMF approvals  Establishment of eCTD submission  Maintenance for 10 product licensesKey skill and responsibility (Additional tasks): Surveyed and designed registration strategies. Developed internal SOPs to meet requirements of Good Submission Practice. Trained RA new members to get the hang of daily tasks quickly.  Timely provided regulatory supports.

Taipei City, Taiwan

Key skill and responsibility: Achieved company’s goals by devoting to product applications and PMF/QSD registrations for drugs and medical devices in a timely manner.  Expedited product approvals and resolved regulatory matters by interacting with regulatory agencies. Maintained company’s licenses and ensured all approved information meets the latest regulations. Handled post-marketing reports including adverse event reports, product complaints and Field Alert Reports for products at US market within timeframe. Managed controlled substances to make sure all procedures meet local regulations. Participated drug development with regulatory concerns.

Taipei City, Taiwan

Key skill and responsibility: Submitted applications for clinical studies to TFDA and IRB in a timely manner.  Managed all aspects of regulatory submissions and maintained internal databases/ systems.

Taipei City, Taiwan

Key skills and responsibility Assisted in submissions of clinical studies.

Master Of Science (M.S.), Pharmacology

Bachelor Of Science (B.S.), Cosmeceutics