Submission Senior Specialist
3 weeks ago
Job Summary
We are seeking a highly skilled Submission Senior Specialist to join our team at Bristol Myers Squibb. As a key member of our regulatory affairs team, you will be responsible for coordinating and managing the submission process for our products.
Key Responsibilities
- Coordinate and manage the submission process for our products, ensuring timely and accurate submissions to regulatory authorities.
- Develop and implement submission strategies to meet business objectives and regulatory requirements.
- Collaborate with cross-functional teams to ensure seamless submission processes.
- Prepare and review submission documents, including cover letters, FDA forms, and submission content plans.
- Facilitate submission team meetings and drive submission publishing timelines.
- Coordinate initial IND kick-off meetings and submissions.
- 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.
- Excellent communication and project management skills.
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