Regulatory Specialist-ii -cta/ind Development Delivery

gssi.world

India
Hybrid
Cta/ind dossier preparation
Regulatory submission experience
Quality checks on dossier content
GSK is seeking a Regulatory Specialist II to support the preparation and delivery of Clinical Trial Applications (CTA) and Investigational New Drug (IND) submissions in a hybrid role based in India. The ideal candidate will have 2 to 5 years of experience in regulatory affairs and strong communication skills

Job Summary

  • Support preparation and delivery of Clinical Trial Application (CTA) and Investigational New Drug (IND) submissions, working closely with global regulatory, clinical, CMC, quality and external partners.
  • This role offers hands-on submission experience, growth in regulatory systems, and the chance to influence work that advances patient-focused science and innovation.
  • Deliver assigned submission components on time and to defined quality standards, identify and escalate risks or missing information that could impact delivery, and communicate status updates and coordinate with cross-functional project teams.

Matching Summary

Match Score: 85

GSK is seeking a Regulatory Specialist II to support the preparation and delivery of Clinical Trial Applications (CTA) and Investigational New Drug (IND) submissions in a hybrid role based in India. The ideal candidate will have 2 to 5 years of experience in regulatory affairs and strong communication skills.

Skills & Requirements

Must-have

  • CTA/IND dossier preparation
  • Regulatory submission experience
  • Quality checks on dossier content
  • Health authority question support
  • Cross-functional team coordination

Nice-to-have

  • Ambitious for patients culture
  • Collaborative work environment
  • Process improvement contribution
  • Advancing patient-focused science

Key Requirements

  • Bachelor's degree in life sciences or related field
  • 2 to 5 years regulatory affairs experience
  • Experience preparing clinical trial dossiers
  • Working knowledge of CTA/IND requirements
  • Experience with submission systems and MS Office

Work Rights

Not specified

Tailored Resume

Cover Letter