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Submission Senior Specialist - CMC

Bristol Myers SquibbIN,TS,Hyderabad

30+ days ago

Job type

Full-time

Job description

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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