Job Posting: Regulatory Specialist – CTA/IND Development Delivery at GSK
About the Company:
GSK is offering an exciting Regulatory Affairs role that enhances documentation knowledge and helps shape systems strategy. Join our Global Labelling team to ensure compliance with GSK procedures and manage labelling updates in the Online Product Authorisation and Lifecycle (OPAL) system.
Position Name:
Regulatory Specialist – CTA/IND Development Delivery
Organization:
GSK
Location:
Bangalore
Salary:
₹4.3 Lakhs to ₹11.9 Lakhs per year
Experience:
0 years / Freshers welcome
Qualifications:
- B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Life Sciences
Responsibilities:
| Task | Description |
|---|---|
| Data Coordination | Coordinate data collection and reporting for compliance with global, regional, and local labelling updates. |
| Report Management | Manage data collection, report dissemination, and follow-up for flagged events. |
| Tool and Process Support | Support the creation of tools and processes for baseline data setup, resource tracking, and forecasting. |
| Performance Improvement | Work with Global Labelling teams to improve performance data visibility and access. |
| Performance Reporting | Assist in generating reports to address performance queries and identify root causes of deviations. |
| System Administration | Administer labelling systems, including training global and local users per GSK policies. |
| IT Coordination | Collaborate with IT Business System Owners to coordinate solutions delivery and support. |
| Communication Channels | Maintain labelling websites, Team sites, and other communication channels. |
| Project Participation | Contribute to projects supporting other labelling functions and process changes within GRA. |
| Risk Escalation | Escalate risks and variances from plan or target when appropriate. |
Basic Qualifications:
- Bachelor’s degree
- Experience with labelling systems, SOPs, and legislative requirements
- Experience with entry, tracking, and registration data management systems
- Regulatory document management experience (e.g., Documentum databases, MS Team sites)
Preferred Qualifications:
- Master’s degree
- Excellent verbal and written communication skills
- Ability to work under time constraints and prioritize tasks
- Adaptability to fast-paced environments with changing circumstances and strategy
- Experience in a regulated environment, ideally in drug development
Meta Description:
Join GSK as a Regulatory Specialist in Bangalore. Freshers welcome. Competitive salary and growth opportunities. Apply now!
