Regulatory Submissions Lead
2 days ago
Bristol Myers Squibb is a global biopharmaceutical leader that delivers innovative, life-changing medicines for patients.
About the RoleAs a Senior Manager, Global Submission Management, Clinical Trials, you will be responsible for managing and coordinating the timely, compliant, and accurate delivery of core submission documents and dossiers to BMS HA/EC Applicants and CROs. You will also participate in the preparation of the CTIS for CT under the EU Regulation.
Duties and Responsibilities- Manage a team of direct reports within the team supporting clinical trial applications.
- Prepare and distribute the global Clinical Trial Application dossier to country applicants and CROs for submission to ECs and HAs.
- Prepare the data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications.
- Ensure consistency of the Clinical Trial application across projects, studies, and countries.
- Lead Program/Study level CTA Tracking Meetings, in preparation of the CTA dossier, ensuring timelines and dossier quality are managed according to expectations.
- Liaise with country offices and central team (Clinical Supply Operations, Operation Leads, Protocol Managers, Medical Monitor, Safety, Quality Person) to ensure that Clinical trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines, and regulations.
You should have a BA/BS degree in a science or technology field and at least 6 years of relevant regulatory submissions experience. Additionally, you should have expert knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities.
The estimated salary for this role is around $120,000 per year, considering the location and industry standards.
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