Bio Rad Labs Hiring Regulatory Affairs Specialist
Experience :
4-6 Years
Salary :
Not Disclosed
Gurgaon, Haryana, India
You Will Be In Charge Of Planning, Organizing, And Directing Regulatory Affairs (RA) And Quality Assurance (QA) Activities In India And Nearby Nations As A RA Specialist I At Bio-Rad Laboratories. In Order To Achieve Company Goals, This Function Entails Making Sure That Quality, Safety, Health, And Environmental Regulations Are Followed.
Position:
Regulatory Affairs Specialist
Department:
Regulatory Affairs
Education:
B.Pharm, M.Pharm, Or B.Tech
Job Lcation :
Gurgaon, Haryana, India
Job Description
How You’ll Make An Impact:
Regulatory Affairs (70%):
Ensure Product Registrations Are Completed According To Plan For India And Neighboring Markets
Maintain Regulatory System Updates And Data Compliance On Veeva Vault RIMS
Coordinate Submission Of New, Variations, And Renewal Registrations And Licenses
Assist In Customer Notifications, Including Reports To Authorities And Manufacturing Division
Maintain Post-Market Vigilance Activities Records And Database
Ensure Compliance With Relevant Environmental, Health, And Safety Regulations
Liaise With Internal Stakeholders And Regulatory Authorities Like CDSCO, NIB, NPPA, Etc.
Quality Assurance (30%):
Support RA-QA Manager In Maintaining The Quality Management System (QMS) According To ISO 9001 & ISO 13485 & ISO 14001
Monitor And Support Ongoing Development And Implementation Of Quality System Improvements
Support Internal And External Audits And Corrective Action Execution
Review Labeling And Mock-Up Packaging Materials For Accuracy And Completeness
Contribute To The Business-Wide Quality Strategy And Objectives
Monitor Quality Trends And Identify Corrective Actions
Requirements:
Bachelor’s Degree In B.Pharm, M.Pharm, Or B.Tech In Pharmacy
4-6 Years Of Experience In A Multinational Organization, With 5 Years In RA And QA In A Regional Sales And Distribution Organization
Hands-On Experience In SAP For RAQA
Experience In Veeva Vault RIMS
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