Assistant Manager-regulatory Affairs

AstraZeneca

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Artwork management system
Qr code serialization implementation
India regulations for labels
** AstraZeneca is seeking an Assistant Manager for Regulatory Affairs to manage artwork and labeling compliance, ensuring alignment with Indian regulations and internal standards. The ideal candidate will have a background in pharmacy or life sciences and experience in artwork management. **

Job Summary

  • Manage artwork requests, ensuring India-specific annotations and addressing comments from overseas sites for final artwork approval.
  • Support QR code/serialization implementation and review/assess impact of new India regulations relevant to labels, ensuring timely implementation with stakeholders.
  • Liaise with overseas manufacturing sites for first launch batch labels and ensure 100% adherence to internal and external labeling requirements.

Matching Summary

Match Score: 75

** AstraZeneca is seeking an Assistant Manager for Regulatory Affairs to manage artwork and labeling compliance, ensuring alignment with Indian regulations and internal standards. The ideal candidate will have a background in pharmacy or life sciences and experience in artwork management. **

Skills & Requirements

Must-have

  • Artwork Management System
  • QR code serialization implementation
  • India regulations for labels
  • Local Health Authorities liaison
  • Internal and external labeling requirements adherence

Nice-to-have

  • Patient-focused biopharmaceutical company
  • Pioneer the future of healthcare
  • Inclusive culture and collaboration
  • Lifelong learning and development

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter