Submission Manager - CMC

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. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Submission Manager-I -CMC    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 Submission Manager-I supports the planning, organization, and review of routine submissions for chemistry, manufacturing and controls (CMC) and regulatory.   Key Responsibilities   ·       Manages and coordinates the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities. Tracks, collects and reviews all components for routine submissions to Health Authorities ·       Support the execution of the Global Submission Plan through collaborating with team members and vendors. ·       Tracks progress of all components for submission to Health Authorities. ·       Interacts with responsible parties to aid in ensuring that components are received in a timely manner and provide direction to assure quality results are produced. ·       Supports research for legal due diligence activities, document and submission management for acquisitions, partnerships and divestitures, assisting in internal audits and regulatory agency inspections. ·       Coordination of the translation document management activities   ·       Other miscellaneous regulatory operational activities (e.g. US export waivers, etc.)   ·       Develop/Update job aid documents for departmental process    Qualifications & Experience   ·         BA/BS degree, science / technology field preferred ·         8+ 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