Emily Chen
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Emily Chen Email & Phone Number

Regulatory Affairs Project Manager at MSD
Location: Taiwan, Taiwan, Taiwan, Province Of China 9 work roles 2 schools
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Current company
MSD
Role
Regulatory Affairs Project Manager
Location
Taiwan, Taiwan, Taiwan, Province Of China
Company size

Who is Emily Chen? Overview

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Quick answer

Emily Chen is listed as Regulatory Affairs Project Manager at MSD, a company with 33210 employees, based in Taiwan, Taiwan, Taiwan, Province Of China. AeroLeads shows a matched LinkedIn profile for Emily Chen.

Emily Chen previously worked as Associate Project Manager, Regulatory Affairs at Msd and Regulatory Affairs Associate at Msd. Emily Chen holds Mbs, Drug Discovery & Development from Rutgers, The State University Of New Jersey-New Brunswick.

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MSD

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Profile bio

About Emily Chen

Emily Chen is a Regulatory Affairs Project Manager at MSD. She possess expertise in drug development, quality assurance, laboratory skills, science communication, molecular microbiology and 28 more skills. She is proficient in English.

Listed skills include Drug Development, Quality Assurance, Laboratory Skills, Science Communication, and 29 others.

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Emily Chen's current company

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MSD
Msd
Regulatory Affairs Project Manager
kenilworth, new jersey, united states
Website
Employees
33210
AeroLeads page
9 roles

Emily Chen work experience

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Regulatory Affairs Project Manager

Current
Msd

Taiwan

  • 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.
Jun 2020 - Present

Associate Project Manager, Regulatory Affairs

Msd

Taiwan

  • 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.
Jun 2017 - Jun 2020

Regulatory Affairs Associate

Msd

Taiwan

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.

Mar 2014 - Jun 2017

Regulatory Affairs Specialist

Sunyan Bio

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

Jun 2013 - Jan 2014

Quality Assurance Intern

Quantex Laboratories

Edison

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.

Oct 2012 - Mar 2013

Research Assistant In Microbiology Lab

  • 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.
Mar 2009 - Apr 2010

Radiology Intern

Uc Davis Medical Center

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

Jan 2009 - Mar 2009

Front Desk Assistant

Mackay Memorial Hospital Obs& Gyn Department

Taiwan

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

Jun 2008 - Aug 2008

Research Assistant In Ecology & Evolution

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

Jan 2008 - Mar 2008
Team & coworkers

Colleagues at MSD

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2 education records

Emily Chen education

FAQ

Frequently asked questions about Emily Chen

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What company does Emily Chen work for?

Emily Chen works for MSD.

What is Emily Chen's role at MSD?

Emily Chen is listed as Regulatory Affairs Project Manager at MSD.

Where is Emily Chen based?

Emily Chen is based in Taiwan, Taiwan, Taiwan, Province Of China while working with MSD.

What companies has Emily Chen worked for?

Emily Chen has worked for Msd, Sunyan Bio, Quantex Laboratories, Uc Davis, and Uc Davis Medical Center.

Who are Emily Chen's colleagues at MSD?

Emily Chen's colleagues at MSD include Daniel Bricker, Dina Sherif, Yiling Lin, Ho Sky, and María Soledad Poblete.

How can I contact Emily Chen?

You can use AeroLeads to view verified contact signals for Emily Chen at MSD, including work email, phone, and LinkedIn data when available.

What schools did Emily Chen attend?

Emily Chen holds Mbs, Drug Discovery & Development from Rutgers, The State University Of New Jersey-New Brunswick.

What skills is Emily Chen known for?

Emily Chen is listed with skills including Drug Development, Quality Assurance, Laboratory Skills, Science Communication, Molecular Microbiology, Genetics, Scientific Writing, and Business Strategy.

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