Regulatory Specialist-ii -cta/ind Development Delivery

GSK

India
Hybrid
Cta/ind dossier preparation
Regulatory submissions
Health authority interactions
GSK is seeking a Regulatory Specialist II in India to support Clinical Trial Application (CTA) and Investigational New Drug (IND) submissions. The ideal candidate will have 2-5 years of relevant regulatory experience, a life sciences degree, and strong communication skills, while enjoying a hybrid work environment with opportunities for professional growth

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.
  • GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together, aiming to positively impact the health of 2.5 billion people by the end of the decade.

Matching Summary

Match Score: 85

GSK is seeking a Regulatory Specialist II in India to support Clinical Trial Application (CTA) and Investigational New Drug (IND) submissions. The ideal candidate will have 2-5 years of relevant regulatory experience, a life sciences degree, and strong communication skills, while enjoying a hybrid work environment with opportunities for professional growth.

Skills & Requirements

Must-have

  • CTA/IND dossier preparation
  • Regulatory submissions
  • Health authority interactions
  • Document collection and tracking
  • Quality checks on dossier content

Nice-to-have

  • Ambitious for patients
  • Accountable for impact
  • Collaborative team player
  • Process improvement contributions

Key Requirements

  • Bachelor’s degree in life sciences or related field
  • 2-5 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