Biotechnology Jobs | GSK is Hiring a Regulatory Specialist | Apply Now
Looking to advance your GSK Career in high-impact Life Science Jobs? GSK is hiring a Regulatory Specialist III, SDE-Investigational in Bengaluru, offering professionals from life sciences and Biotechnology Jobs backgrounds an opportunity to work on global clinical trial submissions and regulatory operations. This role is ideal for candidates seeking growth in regulatory affairs within a world-leading pharmaceutical organization.
Job Details
- Job Title: Regulatory Specialist III, SDE-Investigational
- Location: Bengaluru, India
- Department: Regulatory
- Job ID: 434825
About the Company
GlaxoSmithKline (GSK) is a global biopharmaceutical company focused on uniting science, technology, and talent to get ahead of disease. With strong R&D capabilities and a patient-centric mission, GSK delivers vaccines and medicines that improve global health outcomes. A GSK Career offers meaningful Life Science Jobs driven by innovation, integrity, and impact.
Responsibilities
- Prepare and compile Clinical Trial Application (CTA) packages for EU and non-EU regions
- Support CTA amendments, End of Trial Notifications (EOTN), and EU Study Summary submissions
- Assist with Development Safety Update Reports (DSURs), IND applications, and amendments
- Ensure compliance with Global Regulatory Affairs SOPs and regulatory systems
- Collaborate with cross-functional and global regulatory teams
- Monitor emerging investigational regulatory requirements and communicate risks
Qualifications
- Bachelor’s degree in life sciences, biotechnology, or a related scientific discipline.
- 1–4 years of experience in regulatory affairs, clinical trial applications, or a related role in the pharmaceutical or clinical research environment.
Skills Required
- Knowledge of global pharmaceutical regulatory affairs and submission processes
- Understanding of drug development and clinical trial regulations
- Ability to manage regulatory submission timelines and documentation
- Experience working in matrix and cross-functional teams
- Strong communication, coordination, and problem-solving skills
This Regulatory Specialist III role is an excellent opportunity for professionals seeking to strengthen their GSK Career in global regulatory operations. With exposure to clinical trial submissions, investigational regulations, and cross-regional collaboration, this position offers meaningful growth for candidates pursuing advanced Life Science Jobs in the pharmaceutical industry.
