Regulatory Submission Specialist
5 days ago
Job Summary:
Bristol Myers Squibb is seeking a highly skilled Regulatory Submission Specialist to join our team. This role plays a critical part in the submission of regulatory documents to health authorities.
About the Job:
We are looking for an individual with 3+ years of relevant submissions experience, preferably in a science or technology field. The successful candidate will be responsible for preparing and coordinating regulatory submissions, including Investigational, Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission).
The ideal candidate will have a strong understanding of global regulatory practices, submission guidelines, and requirements. They will assist in implementing short- and long-term goals within their work group and engage stakeholders to help address problems.
The Regulatory Submission Specialist will also be responsible for building and managing CARA/PRISM Structures for Global CMC Submissions, coordinating non-eCTD submissions with International Regulatory Team leads, and developing job aid documents for departmental processes.
Skill Requirements:
To succeed in this role, you should possess foundational knowledge of global regulatory practices, submission guidelines, and requirements. You should also be proficient in the English language, both written and oral, and able to communicate effectively in written form with non-English speakers.
Key Competencies:
The successful candidate will demonstrate basic presentation skills needed to deliver content to a variety of audiences, execute non-complex projects, prioritize tasks with strong attention to detail, and apply critical thinking skills to daily workload decisions.
Estimated Salary: $90,000 - $110,000 per year, based on location and industry standards.
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