Regulatory Affairs Manager II
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About the role
AstraZeneca discovers, develops, and commercializes prescription medicines. You will lead global regulatory maintenance submissions, coordinate labeling updates, and manage related plans and cross-functional deliverables.
What you'll do
- Plan and deliver regulatory maintenance submissions across markets
- Provide regulatory guidance on submission requirements and procedures
- Coordinate development and implementation of global labeling updates
- Maintain submission plans, content plans, and project status
- Identify regulatory risks and propose mitigations
- Contribute to process improvement and share regulatory knowledge
Skills
Must have
- Regulatory affairs
- Regulatory submissions
- Regulatory labeling
- License maintenance
- Project management
- Regulatory compliance
Nice to have
- Us regulatory affairs
Tools
- Veeva vault
- Ms project
Who it's for
- Education
- Bachelor's degree
- Degree
- science
- Experience
- 8+ years
- Domain
- biopharmaceuticals
About AstraZeneca
AstraZeneca has 17 open roles in Bangalore, at AstraZeneca India, Manyata Embassy Business Park. See every AstraZeneca role.
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