Submission Senior Specialist
4 weeks ago
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
Position Summary
Regulatory Information and Submission Management (RISM) is an organization that delivers Health Authority submissions and product data to support the BMS portfolio and provides submission strategies for drug development, drug approval, and maintenance of market approvals and RISM sets the strategic business direction and related processes oversight for GRS systems.
The Senior Submission Specialist supports the planning, organization, and review of routine submissions for chemistry, manufacturing and controls (CMC) and regulatory.
Key Responsibilities
• Tracks, collects and reviews all components for routine submissions to Health Authorities
• Interacts with responsible parties for quality submission documents for routine submissions
• Troubleshoots issues found in components received and interacts with responsible parties for clarification or revision
• Assist with the translation document management activities
• Other miscellaneous regulatory operational activities (e.g. US export waivers, etc.) as needed
• Build/manage dossier structures in the BMS Document Management System (DMS) for global CMC Submissions
• Distribute, Track and Archive non eCTD submissions globally
• Lead contact to ensure Literature References are in the DMS correctly
• Draft eCTD content plans for CMC submissions
Qualifications & Experience
• BA/BS degree, science / technology field preferred
• 3+ years relevant submissions experience
Key Competency Requirements
• Foundational knowledge of global regulatory practices, electronic submission guidelines and requirements
• Communicates questions and issues as they arise with possible solution
• Supports other functions as appropriate
• Participates in submission team meetings
• Effective written and verbal communication skills
• Works with supervision
• Ability to prioritize and strong attention to detail
• Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, eCTD viewers and web based applications) and be technically savvy with such systems.
• Coordinate non-eCTD submissions with ISL Intercon Team
• Independently prepare Cover Letter, FDA Forms and submission content plan for routine maintenance Investigational submissions
• Coordinate submission publishing with vendor/supplier
• Update Verity with US planned submissions and update entries with submitted submissions
• Perform submission verification on published submissions to confirm eCTD compliant
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