Regulatory Affairs Executive | Mumbai

•  Managing regulatory affairs of the organization its subsidiaries / associates.
•  liasoning with regulatory bodies like State and Central FDA, DCI, etc.
• Well conversant with Drug law/feed supplement regulation.
• Co-ordination with factory, purchase department, marketing department.
• Reviewing of technical documents like process validation, stability, etc.
• Compilation of dossiers and handling dossier related queries.
•  Arranging and checking artworks for registration as per guidelines.
• Compilation and preparation of tender documents.
• Support in Site Audit Readiness and Compliance relevant to RA functions / procedures based on external / internal audits.
• To Audit sites to verify the executed documents (Process validation Protocol and reports and BMRs/BPRs) and its accuracy and readiness as per GDP and GMP norms.
• To maintain Data Bank for Commercial activity.
• To work with quality standards and adherence to system

Overview

• Industry - PHARMACEUTICAL / MEDICAL DEVICES / CRO
• Functional Area - Regulatory Affairs / Corporate Affairs
• Job Role - Officer / Executive - Regulatory Affairs
• Employment type - Full Time
• Work Mode - In Office

Qualifications

• B.Pharma - Any Specialization
• MPharma - Any Specialization
• Any Doctorate - Any Specialization

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