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 Manager 1 manages and coordinates the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities.

Position Responsibilities

• Provides advice regarding regulatory and submission requirements, dossier content, and format using in-depth knowledge of eCTD submission production.
• Supports the execution of the Global Submission Plan through collaborating with team members and vendors.
• Tracks progress of all components for submission to Health Authorities.
• Independently facilitate submission team meetings
• 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.
• Attend submission team and kick off meetings, represent SM, drive submission publishing timelines.
• Facilitate Initial IND Kick off meeting submission.
• Coordinate IND, NDA, BLA and Orphan Drug Annual Reports.
• Other miscellaneous regulatory operational activities.
• Develop/Update job aid documents for departmental process.
• May facilitate in focused projects related to their scope of work.

Degree Requirements
BA/BS degree, science / technology field preferred

Experience Requirements
5+ years relevant submissions experience

Key Competency Requirements

• Proficient knowledge of global regulatory practices, submission guidelines and requirements.
• Identifies and resolves issues with the assistance of Sr. team members.
• Collects, collates, and integrates information for solution development, decision-making, and implementation.
• Generates alternative solutions by weighing risks and considering dependencies.
• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers.
• Delivers engaging and effective presentations of increasing complexity.
• Applies basic knowledge of project management methodologies, tools, and templates and assesses information needed to effectively manage projects of increasing complexity from start to finish.
• Defines project objectives, priorities, timelines, and metrics; tracks progress and communicates status; secures needed resources.
• Drives communication within the project team to ensure awareness of risks, issues, and dependencies and collaboration for effective completion of defined deliverables.
• Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives.
• Proposes and implements alternative solutions for submission and/or project related situations.
• Understand stakeholder needs, priorities, working processes, and activities and builds collaborative relationships.
• Solid understanding of desktop application software suites, including effective troubleshooting skills.
• Knowledge and experience with computer systems in an R&D environment.

#HYDDD #LI-Hybrid

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\xe2\x84\xa2 , 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

BMS 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 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.