May Wu
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May Wu Email & Phone Number

Senior RA Specialist at CSL Behring Limited. at CSL
Location: Taiwan, Taiwan, Taiwan, Province Of China 5 work roles 2 schools
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Current company
CSL
Role
Senior RA Specialist at CSL Behring Limited.
Location
Taiwan, Taiwan, Taiwan, Province Of China
Company size

Who is May Wu? Overview

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Quick answer

May Wu is listed as Senior RA Specialist at CSL Behring Limited. at CSL, a company with 14897 employees, based in Taiwan, Taiwan, Taiwan, Province Of China. AeroLeads shows a matched LinkedIn profile for May Wu.

May Wu previously worked as Senior RA Specialist at Csl and Senior Regulatory Affairs Specialist at Orient Pharma Co., Ltd. May Wu holds Master Of Science (M.S.), Pharmacology from National Yang-Ming University.

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CSL

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Profile bio

About May Wu

Experienced Senior Regulatory Affairs Specialist with 7 years of experience in in-licensing products at Taiwan and Southeastern Asia markets as well as local products at US and Taiwan markets.

Listed skills include New Drug Application, Electronic Common Technical Document, Regulatory Guidelines, Pharmaceutical Industry, and 5 others.

Current workplace

May Wu's current company

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CSL
Csl
Senior RA Specialist at CSL Behring Limited.
king of prussia, pennsylvania, united states
Website
Employees
14897
AeroLeads page
5 roles

May Wu work experience

A career timeline built from the work history available for this profile.

Senior Ra Specialist

Current
Csl

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.

Apr 2018 - Present

Senior Regulatory Affairs Specialist

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.

Apr 2017 - Mar 2018

Regulatory Affairs Specialist

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.

Sep 2013 - Mar 2017

In-House Clinical Research Associate

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.

Dec 2012 - Aug 2013

Clinical Trial Assistant

Taipei City, Taiwan

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

Aug 2012 - Nov 2012
Team & coworkers

Colleagues at CSL

Other employees you can reach at csl.com.au. View company contacts for 14897 employees →

2 education records

May Wu education

Master Of Science (M.S.), Pharmacology

National Yang-Ming University
FAQ

Frequently asked questions about May Wu

Quick answers generated from the profile data available on this page.

What company does May Wu work for?

May Wu works for CSL.

What is May Wu's role at CSL?

May Wu is listed as Senior RA Specialist at CSL Behring Limited. at CSL.

Where is May Wu based?

May Wu is based in Taiwan, Taiwan, Taiwan, Province Of China while working with CSL.

What companies has May Wu worked for?

May Wu has worked for Csl and Orient Pharma Co., Ltd.

Who are May Wu's colleagues at CSL?

May Wu's colleagues at CSL include Casey Huss, Eleanor C., Diane Meyers, Teneshia Williams, and Eric Prebe.

How can I contact May Wu?

You can use AeroLeads to view verified contact signals for May Wu at CSL, including work email, phone, and LinkedIn data when available.

What schools did May Wu attend?

May Wu holds Master Of Science (M.S.), Pharmacology from National Yang-Ming University.

What skills is May Wu known for?

May Wu is listed with skills including New Drug Application, Electronic Common Technical Document, Regulatory Guidelines, Pharmaceutical Industry, Regulatory Affairs, Fda, Ectd, and Regulatory Submissions.

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