Looking to advance your career in regulatory affairs and clinical trial submissions? GlaxoSmithKline (GSK) is hiring a Regulatory Specialist-II โ CTA/IND Development Delivery in Mumbai (Worli) and Bangalore.
This opportunity is ideal for professionals with 2โ5 years of regulatory affairs experience, especially those skilled in CTA (Clinical Trial Applications) and IND (Investigational New Drug) submissions.
With GSKโs mission to impact 2.5 billion lives globally, this role places you at the forefront of clinical development and regulatory strategy.
๐ Job Overview
- Position: Regulatory Specialist-II โ CTA/IND
- Company: GlaxoSmithKline (GSK)
- Location: Mumbai (Worli) & Bangalore
- Job Type: Full-Time
- Experience: 2โ5 Years
- Department: Regulatory Affairs / Clinical Development
- Application Deadline: 19 March 2026
๐ Key Responsibilities
As a Regulatory Specialist-II (CTA/IND), you will:
- Compile and deliver CTA/IND regulatory dossiers as per global submission strategy
- Coordinate with clinical, CMC, quality, and external stakeholders
- Perform quality checks for compliance with regulatory requirements
- Maintain regulatory databases and submission tracking systems
- Support health authority queries and follow-ups
- Assist in process improvements and regulatory system testing
- Prepare regulatory correspondence and documentation
- Ensure timely delivery of submission components
๐ Eligibility & Qualifications
Basic Requirements
- Bachelorโs degree in:
- Pharmacy (B.Pharm / M.Pharm)
- Life Sciences
- Chemistry or related field
- 2โ5 years experience in:
- Regulatory Affairs
- Regulatory Operations / Submissions
- Experience with:
- CTA/IND dossier preparation
- Regulatory submission workflows
- Document management systems
Preferred Skills
- Knowledge of eCTD / non-eCTD submissions
- Experience with Veeva Vault or regulatory systems
- Understanding of:
- CMC documentation
- Clinical regulatory requirements
- Experience in clinical research or pharma manufacturing
๐ฐ Salary & Benefits (Estimated)
- Salary Range: โน8 LPA โ โน15 LPA (based on experience)
- Work with a global regulatory team
- Exposure to early-phase drug development
- Career growth in global submissions (CTA/IND)
- Opportunity to work across multiple therapeutic areas
๐ Why This Role is Important
This role is critical in the drug development lifecycle, ensuring that:
- Clinical trials receive regulatory approvals (CTA/IND)
- Submissions meet global compliance standards
- New therapies reach patients faster and safely
If you’re targeting careers in:
- Regulatory Affairs
- Clinical Research
- Global Submissions
๐ This is a high-value strategic role
๐ฅ How to Apply
