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Emily Chen is listed as Regulatory Affairs Project Manager at MSD, a with 33210 employees, based in 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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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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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.
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.
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.
Coordinated product manufacture and registration process with customers, suppliers, and/or contract manufacture organizations. Thoroughly reviewed and checked dossiers against ICH guidelines.
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.
• 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.
Taiwan
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.
Other employees you can reach at msd.com. View company contacts for 33210 employees →
Linda Harouche
Colleague at MsdBeni Mered, Blida, Algeria
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James Watson
Colleague at MsdCounty Dublin, Ireland
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Omar Davila
Colleague at MsdPeru
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Lorcan Hayes
Colleague at MsdCounty Wexford, Ireland
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Nadia Wehrle
Colleague at MsdGennep, Limburg, Netherlands
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Vipin Sahu
Colleague at MsdBilaspur, Chhattisgarh, India
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นลิน บวรศุภศรี
Colleague at MsdBangkok Metropolitan Area, Thailand
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Yi-Jia Lin
Colleague at MsdBangkok City, Thailand
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CM
Clodagh Maguire
Colleague at MsdCounty Carlow, Ireland
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DI
Diego Isaac Rosas Hernandez
Colleague at MsdBenito Juárez, Mexico City, Mexico
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MBS is a professional science master degree that combines an MS with courses from an MBA program.
Quick answers generated from the profile data available on this page.
Emily Chen works for MSD.
Emily Chen is listed as Regulatory Affairs Project Manager at MSD.
Emily Chen is based in Taiwan, Province of China while working with MSD.
Emily Chen has worked for Msd, Sunyan Bio, Quantex Laboratories, Uc Davis, and Uc Davis Medical Center.
Emily Chen's colleagues at MSD include Linda Harouche, James Watson, Omar Davila, Lorcan Hayes, and Nadia Wehrle.
You can use AeroLeads to view verified contact signals for Emily Chen at MSD, including work email, phone, and LinkedIn data when available.
Emily Chen holds Mbs, Drug Discovery & Development from Rutgers, The State University Of New Jersey-New Brunswick.
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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