Job Description

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 rich in diversity. 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: .Functional Area DescriptionThe role is to provide coordination and operational support to cross-functional regulatory teams and Country Regulatory ManagersPosition SummaryThe 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 ResponsibilitiesResponsibilities include but not limited to:Global Regulatory SupportCo-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision makingExecution of Regulatory StrategyLiaise cross-functionally to generate periodic internal milestone reportCommunicate status and timeline changesTracking key regulatory milestones as defined by the GRT, health authority meetings, post-approval commitments, annual reports, etc.Regulatory IntelligenceMonitors key Health Authority Websites for pertinent informationCompiles Regulatory precedents as requestedCreating and supporting database for Global Submission Country requirements (CMC, IVDR,)for new and Post Approval submissionsGlobal Regulatory Submissions SupportSupport CMC Leads to gather auxiliary (country specific) documentation for clinical and commercial Rest of World submissions (non-Module 1. Example: support to collate documents / getting the Annexes for GMP dossiers (e.g. for Turkey, Korea, Thailand)Support submission team meetings ROWSupport of Divestitures / Product Deletions / Product Termination / Asset IntegrationProduct Divestiture:Works with the Divestiture Reg Lead to document any gaps to be disclosed to the buyerWorks with Divestiture Reg Lead on implementation of MAT transfers, provides status updatesHA queries / Shortage NotificationsSchedule RRT meetings and communicate timelinesSet up response templates to ensure submission readinessSubmission of responses for publishingFollow-up with SME in response sectionsAnalytics / Compliance ActivitiesSupport preparation of GRS analytics and monthly dashboards, eg submission, Approvals, key achievements, miles stonesReview Verity and Infinity reports for Compliance related trends, eg HA commitments, Development commitments, openCAPAs, CAPAs coming dueDegree RequirementsMinimum of a Bachelor degree in a Natural Science, Pharmacy, or other Healthcare-related fieldExperience RequirementsQualifications/Requirements:\xe2\x89\xa5 3 years in pharmaceutical industry and regulatory experienceKey Competency RequirementsSolid understanding of at least one major Health Authority (FDA, EMA, MHRA ..) regulations and Regulatory standardsAct as a role model & set a good exampleIdentify, resolve and manage completion of issues. Articulate the implication of issue to and across project team on risk/benefit strategic component.Excellent communication and organizational skills and a meticulous eye for detailsFacilitate negotiation with HAs & key partners on routine matters w/ supervisory consultation.Ability to make decisions in their sphere of influenceIndependently work on multiple projects & assignments.Ability to lead cross-functional teams under supervisionMust 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 neededSolid knowledge of medical and scientific terminology, and biopharma manufacturing complexitiesTravel Required (nature and frequency). Enter N/A if not applicable.N/ADescribe exposure to any hazards/disagreeable conditions in the work environment. Enter N/A if not applicable.NAIf 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 an inclusive culture, promoting diversity 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 ProtocolBMS has a diverse 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.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 . Visit to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol-Myers Squibb