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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 . Job Description Job Title/Role Senior Manager I / Global Regulatory Sciences - CMC Department Name/Functional Area Research and Development / Global Drug Development / Global Regulatory Sciences / Global Regulatory Sciences - Chemistry Manufacturing and Controls (GRS-CMC) Job Description Position Summary The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product's lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products.The GRS-CMC Senior Manager I is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding Clinical trial applications; New marketing applications; HA responses and background packages (including participating / leading HA meetings with support); and/or post-approval submissions. In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS), Global Product Development and Supply (GPS) and/or Cell Therapy Development Operations (CTDO). The GRS-CMC Senior Manager I will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management. Duties/Responsibilities Support project teams (e.g. TPT / CMC, GRT, TTT, MLT, GO Team, etc.) for pipeline products from development through completion of post-marketing commitments and relevant lifecycle management projects driven by research, such as paediatric formulations and line extensions in close partnership with supervisorProvide strategic CMC regulatory expertise for development project teams in close partnership with supervisorProvide strategic input to development & GO teams to mitigate drug supply issues in close partnership with supervisorInterpret global regulations and guidanceIdentify, communicate and propose resolution to routine issuesParticipate in product fact finding meetings with supervisionInterface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisorIdentify, communicate and propose resolutions to routine/complex issuesCommunicate with project teams; with regards to technical issues that may impact regulatory submissions, strategy, or success.Provide technical teams insight into regulatory health authority expectationsIdentify potential risks & help technical teams to formulate mitigation strategies to ensure regulatory successEnsures the necessary updates are provided to team leaders (CMCL, GRL, Line manager etc.)Support the preparation of CMC policies and proceduresUtilize electronic systems for dossier creation and trackingParticipate in/lead teams to assess and educate on global regulatory landscape (e.g., review new policy for comment) and determine impact on global regulatory strategyLooks for opportunities for continuous improvement in processes and technology solutionsEnsure Regulatory Compliance and Data Integrity Accountable for the accurate and timely entry of regulatory information within designated timeframes for assigned products into the Regulatory Information Management system, fostering a culture of quality and compliance across the organization Reporting Relationship Associate Director, Director or Senior Director, Global Regulatory Sciences - CMC Qualifications Minimum BA/BS Degree3-5+ years pharmaceutical or related experience (min BA/BS). 2+ years CMC regulatory or related experienceKnowledge of CMC regulatory requirements for advanced therapies and/or small molecules, biologics, cell therapy during development and post-approval as applicableKnowledge of pharmaceutical development, including advanced therapies and/ or small molecules, biologic, cell therapy upstream and downstream processes, analytical methods, and small molecule or biologic/device combination, cell therapy products as applicableDemonstrated ability to develop/maintain strong working relationships cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independentlyAbility to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timelinessAbility to interpret global regulations and guidance documentsStrong oral and written skillsProficient with electronic systemsThis position may require up to 5% of travel 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 scienceâ„¢ , 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. 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. 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. 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/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
