Assistant Manager-regulatory Affairs (artwork & Packaging)

AstraZeneca

Artwork management system
India specific annotations
Qr code serialization implementation
Understand and ensure operational efficiency of the artwork management system, raising artwork requests with India-specific annotations and approving final artwork files

Job Summary

  • Understand and ensure operational efficiency of the artwork management system, raising artwork requests with India-specific annotations and approving final artwork files.
  • Support the implementation of QR codes/serialization, review new India regulations relevant to labels, and ensure timely implementation with local/global stakeholders.
  • Liaise closely with overseas manufacturing sites for first launch batch labels and ensure 100% adherence to internal and external labeling requirements.

Matching Summary

Understand and ensure operational efficiency of the artwork management system, raising artwork requests with India-specific annotations and approving final artwork files.

Skills & Requirements

Must-have

  • Artwork Management System
  • India specific annotations
  • QR code serialization implementation
  • New India regulations review
  • Local and global stakeholders coordination
  • Adherence to internal and external labelling requirements

Nice-to-have

  • Patient-focused biopharmaceutical company
  • Science-led organization
  • Collaborative and inclusive culture
  • Lifelong learning and development
  • Pioneering the future of healthcare

Key Requirements

  • B. Pharm/ M. Sc qualification
  • 3-6 years experience in India Artwork
  • Knowledge of D&C act for Artwork checklist
  • Conversant with Indian regulations in Artwork development

Work Rights

Not specified

Tailored Resume

Cover Letter