Binita Parikh
Regulatory and Compliance Associate ll @Microbix
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WORK HISTORY
Regulatory and Compliance Associate ll @Microbix
Mississauga, ON, CA
Ensure compliance with design control requirements for new product development.• Review and approve design inputs, outputs, and DHF documentation.• Co-ordinate complaint and manage change control effectively • Support regulatory submissions for FDA, EU Health Canada and MDSAP.• Maintain risk management documentation according to ISO 14971.• Participate in internal audits and quality system improvements.
EDUCATION
K. B. Institute of Pharmaceutical Education & Research
Bachelor of Pharmacy - Credential assessment by WES
SKILLS
ABOUT BINITA PARIKH
Quality and Regulatory professional with 15+ years of experience in pharmaceutical and medical device industries, specializing in quality systems, regulatory compliance, documentation management, and product lifecycle support. Experienced working in GMP-regulated environments with strong knowledge of ICH guidelines, ISO 13485 and FDA, Health Canada, EU international regulatory requirements. Proven ability to collaborate with cross-functional teams and suppliers to maintain high quality standards, support material and product specifications, Design control documents and ensure regulatory compliance across development and manufacturing processes.REGULATED INDUSTRY EXPERIENCEPharmaceuticals | Biotechnology | Medical Devices | GMP-Regulated ManufacturingREGULATORY AND QUALITY ENVIRONMENTGMP | ISO 13485 | ICH Guidelines | Complaints | NDFs | CAPA | Change Control | Risk Management | Internal Audits | Regulatory Inspections Professional Skills:• Quality Management Systems (QMS)• Change Control, NDF/CAPA & Complaint • Label Control & Specifications• Design Control Documentation • Regulatory Submissions (FDA, EU, Health Canada)• Risk Management ISO 14971• Internal Audits & Inspection Readiness • Cross-Functional Collaboration• Supplier Documentation & Quality Coordination • Batch Production RecordsSoftware skills:MS office, ERP, SharePoint, MasterControl, DocuSign etc.
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