Bristol Myers Squibb (BMS) is hiring for the position of Regulatory Specialist, Portfolio Acceleration and Analytics in Hyderabad, Telangana. The role provides coordination and operational support to cross-functional regulatory teams and Country Regulatory teams, supporting regulatory portfolio deliverables, submissions, regulatory intelligence, analytics, and compliance activities.
Job Details
| Details | Information |
|---|---|
| Company | Bristol Myers Squibb (BMS) |
| Job Title | Regulatory Specialist, Portfolio Acceleration and Analytics |
| Job Requisition ID | R1607282 |
| Location | Hyderabad, Telangana, India |
| Employment Type | Full Time |
| Experience | 0–2 years in the pharmaceutical industry |
| Qualification | Bachelor’s degree in Natural Science, Pharmacy, or another Healthcare-related field |
Position
Regulatory Specialist, Portfolio Acceleration and Analytics
The position supports regulatory teams with operational coordination, regulatory submissions, portfolio activities, analytics, compliance, and technology adoption.
Responsibilities
- Maintain SharePoint and support GRT member transitions through operational transition forms.
- Coordinate with cross-functional teams to generate periodic internal milestone reports.
- Perform simple regulatory intelligence analyses as directed.
- Support planning and timely delivery of critical regulatory deliverables, including registration samples and Module 1 documents for ex-US and ex-EU countries.
- Request certificates from Health Authorities including FDA, EMA, and Swissmedic and manage the notification process.
- Support document shipping, scanning, copying, and shipping-label activities.
- Upload relevant documents into Virtual Data Rooms for potential buyers during product divestitures.
- Gather information from Country Regulatory Managers for product deletion strategies and track deletion notifications to country Health Authorities.
- Upload incoming documents to BMS systems during asset integration and ensure correct metadata updates and document remediation.
- Schedule RRT meetings and communicate timelines for Health Authority queries and shortage notifications.
- Set up response templates to support submission readiness.
- Support submission of responses for publishing.
- Support preparation of GRS analytics and monthly dashboards covering submissions, approvals, key achievements, and milestones.
- Apply analytics and technology to business-of-work activities and processes.
Eligibility & Qualifications
Candidates should have:
- A Bachelor’s degree in Natural Science, Pharmacy, or another Healthcare-related field.
- 0–2 years of experience in the pharmaceutical industry.
- Basic understanding of FDA, EMA, or other Health Authorities and reporting regulations and standards.
- Good communication and organizational skills.
- Strong attention to detail.
- Ability to identify and communicate routine issues.
- Ability to establish strong working relationships.
- Ability to work independently on multiple assignments.
- Ability to work effectively as part of a team supporting global functions.
- Excellent command of English.
- Proficiency in standard office technology, including Microsoft Suite and Outlook Mail/Calendar.
- Willingness to learn additional applications as needed.
- Good understanding of pharmaceutical or medical terminology.
Required Skills
Key skills relevant to the Regulatory Specialist role include:
- Regulatory affairs support
- Regulatory submissions
- Regulatory intelligence
- Health Authority coordination
- Pharmaceutical documentation
- Regulatory analytics
- Compliance activities
- Microsoft Suite
- Outlook Mail/Calendar
- Communication and organizational skills
- Attention to detail
- Pharmaceutical and medical terminology
Application Details
