Pharma Job at Bristol | Apply Now for the Submission Specialist Role
Bristol Myers Squibb (BMS) is hiring a Submission Specialist to join its Regulatory Operations team in Hyderabad, India. This Pharma Job is perfect for candidates with 0–2 years of pharmaceutical experience and a foundational knowledge of global regulatory practices. The specialist will be responsible for coordinating, reviewing, and tracking all components for routine submissions to Health Authorities, including preparing Cover Letters and FDA Forms, performing eCTD verification on published submissions, and diligently updating the RIM system to ensure accurate global compliance.
- Job Title: Submission Specialist
- Location: Hyderabad – TS – IN
About The Company
Bristol Myers Squibb (BMS) is a leading global biopharmaceutical company driven by the vision “Transforming patients’ lives through science.” The company focuses on developing life-changing therapies, from optimizing production lines to pioneering cell therapy breakthroughs. BMS fosters a supportive culture built on collaboration, trust, and courage, empowering employees to make a meaningful impact. BMS recognizes the importance of balance and offers comprehensive benefits, providing unique opportunities for growth and professional advancement within a globally scaled organization.
Job Description
Working with Us is challenging, meaningful, and life-changing. Bristol Myers Squibb offers uniquely interesting work every day, from optimizing production lines to breakthroughs in cell therapy. Our high-achieving teams enable you to grow and thrive, taking your career further than possible.
Responsibilities
- Track, collect, and review all components for routine submissions to Health Authorities.
- Interact with responsible parties for quality submission documents for routine submissions.
- Troubleshoot issues found in components and interact 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 compliance.
- Update RIM system with US planned submissions and update entries with submitted submissions.
- Participate in submission team meetings 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 problems appropriately.
- Proficient in English, both written and oral, and able to communicate effectively with non-English speakers.
- Demonstrates basic presentation skills needed to deliver content to various audiences.
- Ability to execute non-complex projects, prioritize tasks, and maintain strong attention to detail.
- Communicates project status and updates appropriately to relevant stakeholders.
- Applies critical thinking skills to daily workload decisions, aligning 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, preferably in a science or technology field.
If a role intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from life-changing work.
