You will be taken to Bristol Myers Squibb’s own careers page to apply. Job ID R1607282.
Job description
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
The role is to provide coordination and operational support to cross-functional regulatory teams and Country Regulatory to ensure regulatory portfolio deliverables are delivered to plan and in compliance with global processes and appropriate local regulatory requirements.
Position Responsibilities
Responsibilities include but not limited to
SharePoint Maintenance Activities; Support GRT member transition by setting up transition form (operational)
Execution of Regulatory Strategy
Liaise cross-functionally to generate periodic internal milestone report
Regulatory Intelligence
Performs simple analyses as directed
Global Regulatory Submissions Support
Support planning and managing timely deliverable of critical regulatory deliverables (registration samples) and various Module 1 documents for ex-US,ex-EU countries
Request certificates from respective Health Authority (FDA, EMA, Swiss Medic) and manage notification process
Shipping of documents, as required
Admin- scanning, copying, shipping label
Support of Divestitures / Product Deletions / Product Termination / Asset Integration
Product Divestiture: Upload relevant documents into the Virtual Data Room (VDR) for potential buyers
Product Deletions: Gather information from the Country Regulatory Managers for Product Deletions Strategy
Tracks deletion notifcations to country Reg HA
Asset Integration: Upload incoming documents to the BMS systems, ensure correct update of meta data; Remediation of documents, as directed
HA queries / Shortage Notifications
Schedule RRT meetings and communicate timelines
Set up response templates to ensure submission readiness
Submission of responses for publishing
Analytics / Compliance Activities Support preparation of GRS analytics and monthly dashboards, eg submission, Approvals, key achievements, miles stones
Technology & Analytics Adoption – Embrace and apply analytics and technologies to the BoW activities and process.
Degree Requirements
Minimum of a Bachelor degree in a Natural Science, Pharmacy, or other Healthcare-related field
Basic understanding of FDA, EMA or other Health Authorities and Reporting regulations and standards;
Act as a role model & set a good example
Identify and communicate routine issues.
Establish strong working relationships
Good communication and organizational skills and a meticulous eye for details
Interact w/ key partners or HA on routine matters w/ supervisory consultation.
Ability to make decisions in their sphere of influence
dependently work on multiple assignments
Ability to work as part of a team that supports global functions with a high level of professionalism in the pharmaceutical and scientific documentation discipline.
Must possess an excellent command of language (English)
Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar and willing to learn additional applications as needed
Good understanding of pharmaceutical or medical terminology
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
How We Work Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
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 qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: 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/
Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1607282 : Regulatory Specialist, Portfolio Acceleration and Analytics
