GSK (GlaxoSmithKline) is a leading global biopharmaceutical company focused on uniting science, technology, and talent to combat diseases. With a strong emphasis on vaccines, specialty medicines, and innovative therapies, GSK operates in key therapeutic areas like infectious diseases, HIV, respiratory/immunology, and oncology.
GSK fosters an inclusive, diverse, and thriving workplace, ensuring employees feel valued, motivated, and empowered to make a difference in global healthcare.
Job Title: CTA/IND Regulatory Specialist
Locations: Bengaluru (Luxor North Tower)
Job Type: Full-time
Posted: Today
Deadline: July 17, 2025 (Only 11 hours left to apply!)
Job ID: 421162 / 421136
Job Description
As a CTA/IND Regulatory Specialist at GSK, you will play a crucial role in regulatory submissions, compliance, and clinical trial applications (CTAs). Your responsibilities will include:
✔ Preparing and reviewing IND (Investigational New Drug) & CTA submissions
✔ Ensuring compliance with global regulatory requirements (FDA, EMA, etc.)
✔ Collaborating with cross-functional teams (R&D, Clinical, Legal)
✔ Managing regulatory documentation and maintaining trial master files (TMFs)
✔ Supporting post-approval regulatory activities
Eligibility & Qualifications
✅ Bachelor’s/Master’s in Pharmacy, Life Sciences, or related field
✅ 2+ years of regulatory affairs experience (CTA/IND submissions preferred)
✅ Knowledge of ICH-GCP, FDA/EMA guidelines
✅ Strong communication & project management skills
✅ Ability to work in a fast-paced, global environment
Benefits at GSK
💼 Competitive salary & performance bonuses
🌍 Global career growth opportunities
🏥 Health & wellness programs
📚 Continuous learning & development
👨👩👧👦 Inclusive & flexible work culture
How to Apply
Deadline: July 17, 2025 (Apply soon—only 11 hours left!)
