Job Summary

The GDO Submission Document Manager leads the development and delivery of clinical and regulatory submission documentation supporting global health authority submissions. This role coordinates cross-functional stakeholders, drives submission readiness, manages risks and timelines, and ensures high-quality, compliant deliverables for regulatory filings. The position combines regulatory operations expertise, project leadership, and strategic problem-solving to support successful drug development programs.

Responsibilities

- Lead the development and delivery of clinical and regulatory submission documentation supporting global health authority submissions.
- Coordinate cross-functional stakeholders.
- Drive submission readiness.




- Manage risks and timelines.
- Ensure high-quality, compliant deliverables for regulatory filings.

Skills

- Regulatory submissions
- Regulatory operations
- Project leadership
- Stakeholder coordination
- Risk management
- Timeline management
- Regulatory filings
- Drug development

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 GDO Submission Document Manager (Hyderabad)
🏢 Bristol-Myers Squibb
📍 Hyderabad