Principal/Owner
CurrentPharma, Dietary Supplement, Med Device, Cosmetic
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@sbcglobal.net
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2 phones found area 616
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Elsa Baker is listed as Principal Regulatory and Quality Consultant at Pilgrim Regulatory Solutions, based in Grand Rapids Metropolitan Area, United States. AeroLeads shows a work email signal at sbcglobal.net, phone signal with area code 616, and a matched LinkedIn profile for Elsa Baker.
Elsa Baker previously worked as Principal/Owner at Pilgrim Regulatory Solutions and Regulatory and Quality Consultant at Pilgrim Regulatory Solutions. Elsa Baker studied at Dordt University.
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AeroLeads found 1 current-domain work email signal for Elsa Baker. Compare company email patterns before reaching out.
Regulatory Affairs and Quality Industry Professional. Expertise in managing all aspects of the legal and scientific bases to globally market medical devices, drugs, cosmetics and dietary supplements.
Listed skills include Regulatory Affairs, Gmp, Fda, Pharmaceutical Industry, and 16 others.
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Pharma, Dietary Supplement, Med Device, Cosmetic
Providing regulatory and quality expertise to the medical device, pharma, consumer healthcare industries. Extensive national brand and private label expertise in consumer products: dietary supplements, cosmetics, OTC drugs and medical devices.
Principal consultant for all aspects of regulatory and quality services, consumer affairs/pharmacovigilance/complaint management, labeling and advertising, supplier quality management, raw material quality, standards development and compliance.
Grand Rapids, Michigan, Us
Managed international regulatory development and change control of medical devices, OTC drugs and cosmetic products.Developed the Complaint Management and MDR/ Adverse Event reporting staff. Identify, implement and validate cloud-based complaint management software solution. Worked with team to mitigate a significant complaint case backlog and expedite case closure times. Facilitated excellent working relationships among the newly formed Regulatory group and all other departments.Managed international product registration programs with major presences in Europe and Canada.Supported compliant product development by establishing standards and regulation framework. Facilitated with R&D and engineering the third-party testing for ISO testing, CE marking, customer quality testing.Developed a labeling quality program. Supported DHF development, FMEA, CAPA and Document Control. Maintained Establishment Licensing and product regulatory listings.
Leadership expertise in managing all aspects of the legal and scientific bases to market drugs, cosmetics and dietary supplements globally. Safety compliance management, specializing in the EU and US markets.
Regulatory Affairs; Expertise in managing all aspects of the legal and scientific bases to market drugs, cosmetics and dietary supplements globally.
Managed legal bases to market OTC drugs, nutritional- and dietary supplements; full product life-cycle management. Investigated consumer complaints and product liability allegations for root cause analysis and corrective actions. Extensive change control, SOP/technical writing, labeling and advertising development, and process improvement experience. Structure-function claim substantiation and notification. Corporate representation to Council for Responsible Nutrition (CRN), CTFA, CHPA. Canadian regulatory management of Natural Health Products, OTC Drugs, Cosmetics.
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Elsa Baker works for Pilgrim Regulatory Solutions.
Elsa Baker is listed as Principal Regulatory and Quality Consultant at Pilgrim Regulatory Solutions.
AeroLeads has found 1 work email signal at @sbcglobal.net for Elsa Baker at Pilgrim Regulatory Solutions.
AeroLeads has found 2 phone signal(s) with area code 616 for Elsa Baker at Pilgrim Regulatory Solutions.
Elsa Baker is based in Grand Rapids Metropolitan Area, United States while working with Pilgrim Regulatory Solutions.
Elsa Baker has worked for Pilgrim Regulatory Solutions, Home Town Properties Corp, Ranir Llc, Alticor Corp. Enterprises Tech. Service, and Alticor/ Amway.
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Elsa Baker studied at Dordt University.
Elsa Baker is listed with skills including Regulatory Affairs, Gmp, Fda, Pharmaceutical Industry, Cross Functional Team Leadership, Sop, Quality System, and Change Control.
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