Submission Manager - Chemistry, Manufacturing and Controls

Submission Manager - CMC Working with Us Challenging. Meaningful. Life-changing. Those arent 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. Youll 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 Perform submission verification on published submissions to confirm eCTD compliant. If you come across a role that intrigues you but doesnt perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting

Work, Life-changing Careers With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work.

This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.

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