Regulatory Specialist III - SDE Investigational

Roles & Responsibilities
• Prepare Clinical Trial Application (CTA) packages for EU and Non-EU regions
• Compile regulatory submission components including Investigator’s Brochure (IB), Protocols, IMPD, and application forms
• Support CTA amendments, EU End of Trial Notifications (EOTN), and study summaries
• Assist in planning and compilation of DSURs, new INDs, and IND amendments
• Ensure activities comply with Global Regulatory Affairs SOPs, Work Instructions, and How-to Guides
• Coordinate submission delivery activities within regulatory operations teams
• Promote and support use of Regulatory Information Management (RIM) systems
• Identify opportunities for process improvement and operational efficiency
• Communicate regulatory risks, issues, and status updates to senior stakeholders
• Support investigational regulatory lifecycle activities as required

Qualification
• Bachelor’s degree in Life Sciences / Pharmacy / Biotechnology or related discipline

Experience
• 1–4 years of experience in Regulatory Affairs or clinical trial submissions
• Hands-on exposure to regulatory submissions such as CTA, IND, and DSUR

Skills
• Strong knowledge of global pharmaceutical regulatory procedures
• Understanding of regulations and standards for clinical trial applications
• Experience with regulatory submission processes (CTA / IND / DSUR)
• Familiarity with Regulatory Information Management (RIM) systems or document repositories
• Ability to work independently and collaboratively in cross-functional global teams
• Good communication, coordination, and problem-solving skills

Preferred Skills
• Experience with CTA / IND preparation and submission
• Knowledge of Asia and Rest-of-World regulatory requirements
• Exposure to quality systems and regulatory compliance activities
• Experience with lifecycle activities such as site registrations, renewals, and variations

About the Organization
GlaxoSmithKline (GSK) – A leading global biopharmaceutical company focused on vaccines and specialty medicines, offering strong career growth and global exposure in regulatory affairs and clinical development.