Job Description

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 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 careers.bms.com/working-with-us. BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation. Position Summary The GRS-CMC Operations Regulatory Services Manager will collaborate with stakeholders across functional area to enhance business processes and provide tactical input for the Information Technology (IT) systems and processes utilized for change control, Regulatory Information Management (RIM), and dossier authoring, publishing and viewing systems. Key Responsibilities Perform routine transactions in the RIM system to support the planning of United States (US) CMC regulatory submissions as the role of US Country Regulatory Manager (CRM) includes bundling and linking pertinent change controls related to the regulatory submissions and documenting planned submission dates. Collaborate with GRS-CMC Leads for planning US commercial and clinical Annual Report submissions. Perform routine transactions in the RIM system to allow the progression and tracking of change control regulatory assessments through dossier submission to Health Authorities. Collaborate with the RIM team to upload Health Authority Correspondences, Commitments and Queries, as well as ensure Product Details are appropriately entered for investigational and marketed applications, in the RIM system. Perform checks to ensure Health Authority Commitments are on track and completed as per assigned due dates. Support the RIM database for Health Authority Queries. Remediate routine CMC Data Quality issues to support the accuracy of data in the RIM system. Provide document support with the CMC dossier authoring tool. Triage Medical Inquiries received from the BMS Medical group and obtain responses from GRS-CMC Leads. Qualifications & Experience Minimum BA/BS degree Minimum of 1 - 2 years pharmaceutical or related experience. Minimum of 1 year CMC regulatory or related experience preferred. Strong oral and written communication skills with the ability to effectively impact project teams with solutions to identified issues. Participate in multifunctional teams. Proficient navigation of electronic systems, including formatting and electronic management of data and information. Ability to perform multiple projects independently. Establish effective working relationships with business units and key business partners to achieve assigned objectives. #HYDDD 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 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 Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. 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 [HIDDEN TEXT]. 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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

foundit