Bristol Myers Squibb (BMS) is hiring a Regulatory Specialist – Portfolio Acceleration and Analytics in Hyderabad, Telangana. This full-time regulatory affairs job offers an opportunity to work on global regulatory submissions, CMC variations, regulatory intelligence, and health authority interactions within a high-impact global pharmaceutical environment.
If you have 2–5 years of experience in international regulatory submissions, Veeva Vault workflows, and global Module 1 requirements, this regulatory affairs position could accelerate your career in regulatory operations and compliance analytics.
📌 Job Overview
- Job Title: Regulatory Specialist – Portfolio Acceleration and Analytics
- Requisition ID: R1598462
- Location: Hyderabad, Telangana, India
- Experience Required: 2–5 years
- Industry: Pharmaceutical / Regulatory Affairs
- Employment Type: Full-Time
This regulatory specialist job in Hyderabad focuses on coordinating global regulatory portfolio deliverables, supporting CMC variation filings, managing health authority queries, and ensuring compliance with FDA, EMA, and international regulatory standards.
🔎 Key Responsibilities
1️⃣ Global Regulatory Submissions Support
- Manage Module 1 documentation for ex-US and ex-EU markets
- Coordinate registration samples and submission deliverables
- Request certificates from Health Authorities (FDA, EMA, Swiss Medic)
- Support publishing and submission response documentation
2️⃣ CMC Variations & Regulatory Strategy
- Prepare and manage CMC variation filings
- Track regulatory milestones and portfolio analytics
- Liaise with cross-functional global regulatory teams
3️⃣ Regulatory Intelligence & Compliance
- Perform basic regulatory analytics and reporting
- Prepare dashboards for submissions, approvals, and milestones
- Support continuous improvement using AI and digital tools
4️⃣ Divestitures & Asset Integration
- Upload documentation into Virtual Data Rooms (VDR)
- Support product deletions and termination strategies
- Ensure accurate metadata updates in BMS systems
5️⃣ Health Authority Queries
- Schedule Regulatory Response Team (RRT) meetings
- Prepare submission-ready response templates
- Manage query tracking and compliance follow-up
🎓 Qualifications & Eligibility
- Bachelor’s degree in Pharmacy, Life Sciences, or Natural Sciences
- 2–5 years of experience in the pharmaceutical regulatory industry
- Strong knowledge of:
- Global Module 1 requirements
- FDA, EMA & international health authority regulations
- CMC variation filings
- Regulatory submissions lifecycle
Technical Skills:
- Advanced proficiency in Veeva Vault
- Experience in regulatory dashboards & reporting
- Strong Microsoft Office skills (Excel, Outlook, PowerPoint)
- Excellent English communication skills
💼 Why Join Bristol Myers Squibb?
- Work with a globally recognized biopharmaceutical leader
- Exposure to global regulatory portfolio management
- Career growth in regulatory operations and analytics
- Flexible hybrid work model (site-by-design)
- Strong culture of innovation, compliance, and inclusion
BMS is known for transforming patient lives through science and offers strong professional development opportunities in regulatory affairs and pharmaceutical analytics.
💰 Salary Estimate (Hyderabad Market)
For a Regulatory Specialist with 2–5 years of experience in Hyderabad:
Estimated Salary Range: ₹8,00,000 – ₹14,00,000 per annum (CTC)
(Based on Hyderabad pharmaceutical regulatory affairs market benchmarks)
📩 How to Apply
