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, focusing on artwork management, compliance with local and global regulations, and collaboration with cross-functional teams. The ideal candidate should have a B. Pharm/M.Sc. and 3-6 years of experience in artwork requirements specific to India. **

Job Summary

  • The Assistant Manager-Regulatory Affairs will be responsible for artwork management, supporting QR code/serialization implementation, and reviewing new India regulations relevant to labels.
  • This role involves close liaison with overseas manufacturing sites, ensuring 100% adherence to internal and external labelling requirements, and preparing for audits.
  • AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to being a Great Place to Work, fostering an inclusive culture and empowering employees to push the boundaries of science.

Matching Summary

Match Score: 75

** AstraZeneca is seeking an Assistant Manager for Regulatory Affairs, focusing on artwork management, compliance with local and global regulations, and collaboration with cross-functional teams. The ideal candidate should have a B. Pharm/M.Sc. and 3-6 years of experience in artwork requirements specific to India. **

Skills & Requirements

Must-have

  • Artwork management system
  • QR code serialization implementation
  • India regulations for labels
  • Local and global stakeholder coordination
  • Audit preparation and CAPA implementation
  • Adherence to internal and external labelling requirements

Nice-to-have

  • Patient-focused biopharmaceutical company
  • Pioneering the future of healthcare
  • Inclusive culture championing diversity
  • Lifelong learning growth and development
  • Entrepreneurial spirit

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