16 Aurobindo Pharma Jobs

Role & responsibilities

• Collaborate with cross-functional teams to gather product information for initiating labeling activities related to new dossiers, query responses, commercial manufacturing updates, or variation submissions.
• Prepare and validate SPL using tools and troubleshoot any validation errors.
• Review and compile labeling documents under eCTD Module 1 ensuring accuracy and compliance.
• Submit SPLs and other regulatory documents to the US FDA through the ESG.
• Manage SPL submissions to DailyMed, and communicate acknowledgements and submission receipts to the US Regulatory team.

Preferred candidate profile

- Experience with eCTD publishing tools

- Strong understanding of FDA regulatory requirements

- Excellent coordination, communication, and attention to details