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Sumeet Parwe, Ms Bme, Rac is listed as Regulatory Affairs | Combination Products at Emergent BioSolutions, based in San Francisco Bay Area, United States, United States. AeroLeads shows a work email signal at abbott.com and a matched LinkedIn profile for Sumeet Parwe, Ms Bme, Rac.
Sumeet Parwe, Ms Bme, Rac previously worked as Sr. Manager Regulatory Affairs at Emergent Biosolutions and Regulatory Affairs Manager at Abbott. Sumeet Parwe, Ms Bme, Rac holds Master'S, Biomedical Engineering from University Of Southern California.
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AeroLeads found 1 current-domain work email signal for Sumeet Parwe, Ms Bme, Rac. Compare company email patterns before reaching out.
I am a graduate from USC with thorough knowledge of FDA Regulations relating to the medical devices, drugs, combination products, dietary supplements & cosmetics.
Listed skills include Validation, Capa, Quality Assurance, Medical Devices, and 11 others.
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A career timeline built from the work history available for this profile.
Gaithersburg, Maryland, US
Pre-IND meeting, IND, NDA for Drug-Device Combination Product (Autoinjector, Nasal Spray), Type C meetings, Review & Approve change control & labeling, Regulatory Strategy for new medical devices.
Abbott Park, Illinois, US
FDA pre-sub/Q-sub submissions, Fax-back & ITAs for Health Canada, review product labeling and change controls for SaMD and Medical Device with iOS & Android app.
Abbott Park, Illinois, US
Post approval supplements (30 Day Notice, RTR) for PMA combination products, notified body change notification submissions, FDA pre-sub/Q-sub submissions, annual reports, review product labeling, change controls.
Dublin, IE
Post approval supplements (CBE-30, PAS), annual reports, design controls for drug-device combination product, review product labeling, change controls and promotional material for product with boxed warning, establishment registration and product listing, FDA audit, board of pharmacy audit, state licensing, drug sample reporting
Schaumburg, Illinois, US
Develop and implement Regulatory department’s policies and SOPs, 510(k) premarket notification, design dossier, OPDP submission, annual report, UDI, review product labeling and advertisement (medical devices, cosmetics, dietary supplement, OTC and prescription drugs), establishment registration, product listing, CFG, CPP, ESG Gateway, eMDRs, CDER Direct.
Class III recall, GS1 barcode system (UDI), machine validation (IQ/OQ/PQ), complaint handling, review and approve product labeling, review and approve DMR and technical files, CAPA, incoming inspection, in-process inspection, line clearance, BHR review, FDA and notified body audits
Server patch management, troubleshooting software related issues, creating SOP, maintaining the department website, recording lectures, creating & publishing the E-Learning modules with incorporated slides, audio & video.
Complaint handling, root cause investigation, CAPA
Other employees you can reach at emergentbiosolutions.com. View company contacts →
Amira Parker
Colleague at Emergent Biosolutions
Baltimore, Maryland, United States, United States
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JC
Jr Chase
Colleague at Emergent Biosolutions
Rockville, Maryland, United States, United States
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DD
Danae Dawkins
Colleague at Emergent Biosolutions
Baltimore, Maryland, United States, United States
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RG
Rose Grant
Colleague at Emergent Biosolutions
Canada, Canada
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MB
Micah Burrell
Colleague at Emergent Biosolutions
Baltimore, Maryland, United States, United States
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CG
Coleen Glessner
Colleague at Emergent Biosolutions
Greater Seattle Area, United States, United States
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PP
Peter Peters
Colleague at Emergent Biosolutions
Greater Winnipeg Metropolitan Area, Canada
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DB
Derrell Barnhill
Colleague at Emergent Biosolutions
Waterbury, Connecticut, United States, United States
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AH
Aswani Hemmings
Colleague at Emergent Biosolutions
Gaithersburg, Maryland, United States, United States
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MJ
Mylin Jaramilla, Cpa,Cga
Colleague at Emergent Biosolutions
Canada, Canada
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Quick answers generated from the profile data available on this page.
Sumeet Parwe, Ms Bme, Rac works for Emergent BioSolutions.
Sumeet Parwe, Ms Bme, Rac is listed as Regulatory Affairs | Combination Products at Emergent BioSolutions.
AeroLeads has found 1 work email signal at @abbott.com for Sumeet Parwe, Ms Bme, Rac at Emergent BioSolutions.
Sumeet Parwe, Ms Bme, Rac is based in San Francisco Bay Area, United States, United States while working with Emergent BioSolutions.
Sumeet Parwe, Ms Bme, Rac has worked for Emergent Biosolutions, Abbott, Avadel Pharmaceuticals (Past Flamel Technologies), Sunstar Americas, and Viscot Medical.
Sumeet Parwe, Ms Bme, Rac's colleagues at Emergent BioSolutions include Amira Parker, Jr Chase, Danae Dawkins, Rose Grant, and Micah Burrell.
You can use AeroLeads to view verified contact signals for Sumeet Parwe, Ms Bme, Rac at Emergent BioSolutions, including work email, phone, and LinkedIn data when available.
Sumeet Parwe, Ms Bme, Rac holds Master'S, Biomedical Engineering from University Of Southern California.
Sumeet Parwe, Ms Bme, Rac is listed with skills including Validation, Capa, Quality Assurance, Medical Devices, Iso 13485, Regulatory Affairs, Quality System, and Iso 14971.
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