Freshers Pharma Job Vacancy at Bristol Myers Squibb | Apply Now
Bristol Myers Squibb (BMS) is hiring a Regulatory Specialist, Portfolio Acceleration and Analytics for its Hyderabad office. This entry-to-junior level Pharma Job (0-2 years experience) is ideal for Pharmacy or Science graduates looking to support global regulatory submissions, manage Health Authority queries, and leverage digital tools like Veeva Vault. The specialist in this Pharma Freshers Job will coordinate cross-functional teams to ensure regulatory portfolio deliverables meet global compliance standards.
- Job Position: Regulatory Specialist, Portfolio Acceleration and Analytics
- Location: Hyderabad, Telangana, India
- Job ID: R1598462
About The Company
Bristol Myers Squibb is anything but a “usual” workplace. The company prides itself on a culture that balances challenging work with flexibility and competitive benefits. At BMS, every department—from production to cell therapy breakthroughs—contributes to transforming patient lives. The Hyderabad site is integral to BMS’s global participation in clinical trials and regulatory excellence. Employees work alongside high-achieving teams in an environment that encourages “uncommon scale and scope” for career growth.
Role Summary
As a Regulatory Specialist, you will provide the operational “engine room” support for cross-functional regulatory teams. Your goal is to ensure that portfolio deliverables such as global submissions, registration samples, and Health Authority (HA) responses are delivered on time and in full compliance with global and local requirements.
Key Responsibilities
1. Global Submission & Operational Support
- Module 1 Management: Support planning and delivery of critical Module 1 documents for ex-US and ex-EU countries.
- HA Certificates: Request certificates from Health Authorities (FDA, EMA, Swiss Medic) and manage the notification processes.
- Logistics: Manage the shipping of documents and registration samples required for global filings.
2. Lifecycle & Asset Management
- Divestitures & Deletions: Upload documents into Virtual Data Rooms (VDR) for buyers and track deletion notifications to Country Regulatory Managers.
- Asset Integration: Upload incoming documents to BMS systems and remediate metadata to ensure database integrity.
- Portfolio Intelligence: Perform simple regulatory analyses and maintain SharePoint transition forms for team members.
3. Analytics & HA Queries
- Response Readiness: Schedule Rapid Response Team (RRT) meetings for Health Authority queries and set up response templates.
- Dashboards: Prepare monthly GRS (Global Regulatory Strategy) analytics and dashboards tracking submissions, approvals, and milestones.
- Process Improvement: Identify opportunities to use AI and digital technologies to scale regulatory operations.
Requirements
- Education – Bachelor’s degree in Pharmacy, or a healthcare-related field.
- Experience – 0 – 2 years in the pharmaceutical industry.
- Tools – Proficiency in Veeva Vault (regulatory operations workflows) and Microsoft Suite.
- Knowledge – Basic understanding of FDA, EMA, and global Module 1/CMC variation filings.
- Skills – Meticulous attention to detail, strong English command, and ability to work independently.
