Senior Submission Specialist
4 days ago
Transforming Lives through Regulatory Excellence
Bristol Myers Squibb is a global leader in the pharmaceutical industry, and we're seeking a highly skilled Senior Submission Specialist to join our team. As a key member of our Regulatory Information and Submission Management (RISM) organization, you will play a critical role in delivering high-quality submissions to health authorities and supporting the development of innovative solutions.
Key Responsibilities:
- Track, collect, and review all components for routine submissions to health authorities
- Interact with responsible parties for quality submission documents for routine submissions
- Troubleshoot issues found in components received and interact with responsible parties for clarification or revision
- Assist with translation document management activities
- Perform other miscellaneous regulatory operational activities as needed
Qualifications & Experience:
- Bachelor's degree in a science or technology field
- 3+ years of relevant submissions experience
Competency Requirements:
- Foundational knowledge of global regulatory practices, electronic submission guidelines, and requirements
- Effective written and verbal communication skills
- Ability to prioritize and strong attention to detail
About Bristol Myers Squibb:
Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Our company is committed to making a positive impact on the lives of patients and their families, and we're seeking talented individuals like you to join our team.
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