Regulatory Submissions Specialist
1 week ago
Job Summary:
The Regulatory Submissions Specialist will be responsible for coordinating and managing the submission process for Investigational, Marketed Applications submissions. This includes preparing Cover Letters, FDA Forms, and submission content plans, as well as facilitating submission team meetings and coordinating non-eCTD submissions.
Key Responsibilities:
- Coordinate and manage submissions for Investigational, Marketed Applications submissions
- Prepare Cover Letters, FDA Forms, and submission content plans
- Facilitate submission team meetings and drive submission publishing timelines
- Coordinate non-eCTD submissions with International Regulatory Team lead
- Develop and update job aid documents for departmental processes
- Build and manage CARA/PRISM Structures for Global CMC Submissions
Requirements:
- Bachelor's degree in a science or technology field
- 3+ years of relevant submissions experience
- Foundational knowledge of global regulatory practices, submission guidelines, and requirements
Skills:
- Strong communication and organizational skills
- Ability to prioritize tasks and execute non-complex projects
- Proficient in English language, both written and oral
Bristol Myers Squibb is a leading biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines to patients around the world.
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