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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 doesn’t 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. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1604665 : Submission Manager - CMC