Kavnit Kaur

Regulatory Affairs Manager @Bpr Medical

Dunstable, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

May 2025 — Present

Regulatory Affairs Manager @Bpr Medical

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Mansfield, GB

EDUCATION

2010 — 2011

Nalsar University of law

PG Diploma, Patent Laws

1997 — 2003

Guru Harkrishan Public School ,Jammu

12th Standard

2010 — 2011

Bioinformatics Institute of India

PG Diploma, Pharmacovigilance and clinical data management

2014 — 2015

Institute of Goods Manufacturing Practices

Executive Diploma in Regulatory Affairs, Regulatory Affairs

2010 — 2012

Sikkim Manipal University

Master of Business Administration (MBA), Quality Control Technology/Technician

2014 — 2014

TÜV SÜD

Lead Auditor – ISO 9001: 2008 from TÜV SÜD, Lead Auditor

2006 — 2008

Guru Nanak Dev University

Master's degree, Biotechnology

2003 — 2006

Guru Nanak Dev University

Graduation, Biotechnology

SKILLS

PharmacovigilanceGmpQuality SystemIch-GcpV&VRegulatory RequirementsMicrosoft OfficePharmaceuticsRegulatory AffairsPharmaceutical IndustrySopFdaMarket ResearchFormulationChange ControlGlpStrategic PlanningValidation21 Cfr Part 11Pharmaceutical SalesMicrosoft ExcelHplcGcpBiotechnologyTechnology TransferRegulatory SubmissionsMedical DevicesClinical ResearchCapaCleaning ValidationClinical TrialsClinical Data ManagementAndaMarketing Strategy

ABOUT KAVNIT KAUR

A passionate professional, result driven and committed in producing excellent results through due diligence and meticulous approach to work.Great ability to build rapport with diverse workforce in multicultural settings.Regulatory professional with MBA,Masters, Bachelors in Biotechnology and Diploma in patent laws,clinical data management and pharmacovigilance.•Over 2 years of experience working on European, South East Asian, Latin American and India dossier preparation and compilation for Abbreviated New Drugs Approval.•In depth understanding of guidelines for the biologics and have 3 years of experience in analyzing the documents for registration,import and marketing for biologics. Sound understanding of concept of guidelines of registration and import for medical device, warehouse license requirements, tender documents, device master and plant master file.

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Kavnit Kaur — Regulatory Affairs Manager at Bpr Medical in Dunstable, GB | Unifers