Regulatory Affairs Manager I
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About the role
AstraZeneca discovers, develops, and commercializes prescription medicines. This individual contributor will lead global regulatory maintenance submissions, manage product labeling, and coordinate regulatory deliverables across teams and regions.
What you'll do
- Plan and deliver regulatory maintenance submissions across markets
- Provide regulatory guidance on submission procedures and documentation
- Coordinate development and implementation of revised product labeling
- Maintain submission plans and track deliverables using digital tools
- Identify regulatory risks and propose mitigations
- Contribute to process improvement and share regulatory knowledge
Skills
Must have
- Regulatory affairs
- Regulatory submissions
- Regulatory labeling
- Regulatory product maintenance
- Project management
Nice to have
- Us regulatory affairs
Tools
- Veeva vault
- Ms project
Who it's for
- Education
- Bachelor's degree
- Degree
- science
- Experience
- 6+ years
- Languages
- english
- 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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