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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.

๐Ÿ“ Location: Hyderabad, India
๐Ÿ“… Posted: Today
๐Ÿ“Œ Job Type: Full-time
๐Ÿ”– Requisition ID: R1593101


Detailed Job Description

Key Responsibilities:

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

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Skills & Competencies:

๐Ÿ”น Regulatory Knowledge: Understanding of global submission guidelines (eCTD, FDA, etc.).
๐Ÿ”น Attention to Detail: Strong organizational skills for accurate document handling.
๐Ÿ”น Communication: Proficient in English (written & verbal) for cross-functional collaboration.
๐Ÿ”น Tech-Savvy: Experience with RIM systems, MS Office, and regulatory publishing tools.
๐Ÿ”น Problem-Solving: Ability to escalate and resolve issues efficiently.


Eligibility & Requirements

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


Benefits at Bristol Myers Squibb

๐Ÿ’ผ Career Growth: Uncommon opportunities for professional development.
๐ŸŒ Work-Life Balance: Flexible policies and wellness programs.
๐Ÿฅ Health & Well-being: Comprehensive medical and insurance benefits.
๐Ÿค Inclusive Culture: Commitment to diversity and employee support.
๐Ÿ“ˆ 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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