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Submission Specialist

Submission Specialist

Bristol Myers Squibb

2 - 5 years

4 - 8 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

excel pharmaceutical project management writing life sciences scope management english language communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are looking for a highly skilled and detail-oriented Submission Specialist to join our team in Mumbai. The ideal candidate will have 0-2 years of experience in the pharmaceutical industry, with a strong understanding of global regulatory practices and submission guidelines.

Roles and Responsibility

Tracks, collects, and reviews all components for routine submissions to Health Authorities.
Interacts with responsible parties for quality submission documents for routine submissions.
Troubleshoots issues found in components received and interacts with responsible parties for clarification or revision.
Prepares Cover Letter, FDA Forms, and submission content plan for routine submissions.
Verifies published submissions to confirm eCTD compliance.
Updates RIM system with US planned submissions and updates entries with submitted submissions.
Participates in submission team meetings as applicable and coordinates non-eCTD submissions with International Regulatory Team lead.
Performs other miscellaneous regulatory operational activities as needed.

Job Requirements

BA/BS degree in science or technology field preferred.
Foundational knowledge of global regulatory practices, submission guidelines, and requirements.
Understanding of resolving issues promptly.
Proficient in English, both written and oral, and able to communicate effectively in written form with non-English speakers.
Demonstrates basic presentation skills to deliver content to various audiences.
Ability to execute non-complex projects with strong attention to detail.
Applies critical thinking skills to daily workload decisions, aligning with group/company objectives.
Good understanding of desktop application software suites and practical knowledge of computer systems in an R&D environment.
Practical knowledge of computer systems in an R&D environment.

About Company

Bristol Myers Squibb India Pvt.LTD. is a leading healthcare company committed to transforming patients' lives through innovative science. We offer a wide variety of competitive benefits, services, and programs that support our employees' growth and well-being.

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Bristol Myers Squibb

Pharmaceutical Manufacturing

Lawrence Township NJ

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Submission Specialist