Poorti Chopra-Patel

Regulatory Affairs Specialist - Us Cleaning and Professional Products @The Clorox Company

Brampton, ON, CA
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2023 — Present

Regulatory Affairs Specialist - Us Cleaning and Professional Products @The Clorox Company

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US

EDUCATION

2001 — 2004

UWCSEA

Diploma

2012 — 2012

Seneca College of Applies Arts and Technology

Post Graduate Certification

2004 — 2008

York University

B.Sc. Hons

1996 — 2001

St Anthonys Girls High School

High School

SKILLS

Regulatory DocumentationCorrective and Preventive Action (Capa)GmpNdsEctdPharmaceutical IndustryGcpHplcRegulatory AffairsProject PlansQuality ControlXmlRegulatory FilingsDocumentationSopDinRegulatory SubmissionsLaboratory SkillsTherapeutic Product Directorate (Health Canada)MicrobiologyValidationFda GmpStandard Operating Procedure (Sop)Regulatory ComplianceClass Ii Medical DevicesMicrosoft OfficeU.s. Food and Drug Administration (Fda)Regulatory RequirementsFdaChange ControlU.s. Title 21 Cfr Part 11 RegulationCapaSplGlpCross-Functional Team LeadershipBiochemistrySoftware DocumentationQuality AssuranceSoftware Quality AssuranceMedical Devices

ABOUT POORTI CHOPRA-PATEL

A self-motivated Pharmaceutical Regulatory Affairs and Quality assurance professional with strong analytical skills, digital transformation and adaption sklills and execution capabilities in emerging and developed markets such as USA, Canada, and other global markets My work experience includes working with GreenField Project to experience in authoring regulatory documentation for New Drug Applications, NPN applications, Cosmetics Notifications and Medical Device Applications within Canada and SPL and PM for US & Canada. I have a sound Quality background as well with knowledge in Change control, Deviation reports, CAPA implementation, Exit reports and GMP. A great depth of knowledge in various EDM software (PLM, SAP, Enginuity, Master Control) and quick learning capabilities of new ones (Veeva Vault, ALICE, A4L). I am a hardworking, fast learner and highly motivated individual. I enjoy working in a team environment and working individually. With the experience I have gained, skills like attention to detail and organization are second nature to me. My extrovert nature and work experiences have enhanced my communication and interaction abilities greatly. I am also GCP certified enabling me to work with a proficient background in the Clinical Research field.

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Poorti Chopra-Patel — Regulatory Affairs Specialist - Us Cleaning and Professional Products at The Clorox Company in Brampton, ON, CA | Unifers