Regulatory Specialist-ii -cta/ind Development Delivery

Gsicareers

India
Hybrid
Cta/ind dossier preparation
Document collection coordination
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. The ideal candidate will have a background in life sciences and regulatory affairs, with experience in dossier preparation and compliance with regulatory standards

Job Summary

  • You will support preparation and delivery of Clinical Trial Application (CTA) and Investigational New Drug (IND) submissions.
  • 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.

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. The ideal candidate will have a background in life sciences and regulatory affairs, with experience in dossier preparation and compliance with regulatory standards.

Skills & Requirements

Must-have

  • CTA/IND dossier preparation
  • document collection coordination
  • quality checks on dossier content
  • regulatory systems maintenance
  • health authority question support

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 document management systems

Work Rights

Not specified

Tailored Resume

Cover Letter