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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.
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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
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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.
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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