Senior Regulatory Specialist
4 weeks ago
Transforming Lives, One Submission at a Time
Bristol Myers Squibb is a place where innovation meets impact. As a Senior Diversity and Inclusion Specialist, you'll play a critical role in shaping the future of healthcare. Our team is dedicated to delivering high-quality submissions to health authorities, and we're looking for a skilled professional to join our ranks.
About the Role
The Senior Specialist will be responsible for managing and coordinating the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities. This includes tracking, collecting, and reviewing all components for submission, interacting with responsible parties for quality submission documents, and facilitating submission team meetings.
Key Responsibilities
- Ensure seamless submission processes, from initial planning to final delivery.
- Collaborate with cross-functional teams to drive submission excellence.
- Develop and maintain job aid documents to support departmental processes.
- Coordinate non-eCTD submissions with international regulatory teams.
- Prepare and review submission content plans, cover letters, and FDA forms.
- Represent RISM in submission team meetings and drive publishing timelines.
What We're Looking For
- BA/BS degree in a science or technology field.
- 3+ years of relevant submissions experience.
Why Join Us?
Bristol Myers Squibb offers a dynamic work environment, competitive benefits, and opportunities for growth and development. If you're passionate about regulatory affairs and committed to delivering exceptional results, we encourage you to apply for this exciting opportunity.
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