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Regulatory Submission Management Role at Bristol Myers Squibb

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Bristol Myers Squibb (BMS) is a global biopharmaceutical leader committed to discovering, developing, and delivering innovative medicines for patients battling serious diseases. With a mission to transform patients’ lives through science, BMS fosters a culture of passion, innovation, and inclusion, offering employees unparalleled career growth in a dynamic work environment.

📍 Location: Hyderabad, India
📅 Posted: Today
📌 Job Type: Full-time
🔖 Requisition ID: R1593101


Detailed Job Description

Key Responsibilities:

✔ Track, collect, and review regulatory submission components for Health Authorities.
✔ Prepare Cover Letters, FDA Forms, and submission plans for routine submissions.
✔ Verify eCTD compliance and update Regulatory Information Management (RIM) systems.
✔ Troubleshoot submission issues and collaborate with stakeholders for resolution.
✔ Coordinate non-eCTD submissions with International Regulatory Teams.
✔ Participate in submission team meetings and support regulatory operations.

Skills & Competencies:

🔹 Regulatory Knowledge: Understanding of global submission guidelines (eCTD, FDA, etc.).
🔹 Attention to Detail: Strong organizational skills for accurate document handling.
🔹 Communication: Proficient in English (written & verbal) for cross-functional collaboration.
🔹 Tech-Savvy: Experience with RIM systems, MS Office, and regulatory publishing tools.
🔹 Problem-Solving: Ability to escalate and resolve issues efficiently.


Eligibility & Requirements

✅ Education: B.Pharm / M.Pharm
✅ Experience: Minimum 3 years in regulatory submissions & publishing.
✅ Location: Hyderabad (On-site role)
✅ Skills: Knowledge of eCTD, FDA submissions, and regulatory operations.

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Benefits at Bristol Myers Squibb

💼 Career Growth: Uncommon opportunities for professional development.
🌍 Work-Life Balance: Flexible policies and wellness programs.
🏥 Health & Well-being: Comprehensive medical and insurance benefits.
🤝 Inclusive Culture: Commitment to diversity and employee support.
📈 Innovation-Driven: Work on cutting-edge therapies that save lives.


How to Apply

Application Link

Regulatory Submission Management Role at Bristol Myers Squibb

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