Submission Specialist

Location: Prakāshamnagar

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  .

Responsibilities

Tracks, collects, and reviews all components for routine submissions to Health Authorities.
Interacts with responsible parties for quality submission documents for routine submissions.
Troubleshoots issues found in components received and interacts with responsible parties for clarification or revision.
Prepare Cover Letter, FDA Forms and submission content plan for routine submissions.
Perform submission verification on published submissions to confirm eCTD compliant
Update RIM system with US planned submissions and update entries with submitted submissions.
Participates in submission team meeting as applicable Coordinate non-eCTD submissions with International Regulatory Team lead.
Other miscellaneous regulatory operational activities as needed.

Qualification

0-2 years pharmaceutical experience
Foundational knowledge of global regulatory practices, submission guidelines and requirements.
Understands the importance of resolving issues in a timely manner.
Escalates questions and issues as they arise.
Engages relevant stakeholders to help address the problem, as appropriate.
Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers.
Demonstrates basic presentation skills needed to deliver content to a variety of audiences.
Demonstrates the ability to execute a non-complex project, including the ability to prioritize tasks with strong attention to detail.
Communicates project status and updates, as appropriate, to relevant stakeholders.
Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives
Seeks to understand stakeholder needs, priorities, working processes, and activities.
Good understanding of desktop application software suites.
Practical knowledge of computer systems in an R&D environment.

Degree Requirement

BA/BS degree, science / technology field preferred.

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 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…