Pharma Job for Freshers at Bristol | Apply Now for the Submission Specialist Role
Bristol Myers Squibb (BMS) is recruiting for a Submission Specialist in Hyderabad, Telangana. This Pharma Job, which requires 0-2 years of pharmaceutical experience, focuses on regulatory operations for routine submissions to Health Authorities. The specialist will be responsible for tracking, collecting, and reviewing submission components, performing submission verification on published submissions to confirm eCTD compliance, and updating the RIM system with planned and submitted US entries. A BA/BS degree is required, preferably in a science or technology field.
- Job Post: Submission Specialist
- Location: Hyderabad – TS – IN
About the Company
Bristol Myers Squibb (BMS) is a global biopharmaceutical company dedicated to “Transforming patients’ lives through science™”. BMS offers uniquely interesting and life-changing work daily, operating with shared values of passion, innovation, urgency, accountability, inclusion, and integrity. The company’s work environment emphasizes balance and flexibility, supporting employees with resources to pursue both professional and personal goals. BMS is committed to global participation in clinical trials and fostering an inclusive culture.
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 compliance.
- Update RIM system with US planned submissions and update entries with the submitted submissions.
- Participates in submission team meeting as applicable. Coordinate non-ECTD submissions with the International Regulatory Team lead.
- Other miscellaneous regulatory operational activities as needed.
Qualification
- 0-2 years of pharmaceutical experience.
- Foundational knowledge of global regulatory practices, submission guidelines, and requirements.
- Understands the importance of resolving issues promptly.
- 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.
Education Requirement
BA/BS degree, science/technology field preferred.
