GSK is a leading global biopharma company committed to uniting science, technology, and talent to get ahead of disease. With a focus on vaccines, specialty medicines, and innovative therapies, GSK operates across infectious diseases, HIV, respiratory/immunology, and oncology.
GSK fosters an inclusive, collaborative culture where employees thrive while making a global health impact.
Detailed Job Description
Job Title: Submission Specialist
Locations:
- Mexico City (Torre Mitikah)
- Bengaluru (Luxor North Tower)
Job Type: Full-time
Application Deadline: July 26, 2025 (10 days left)
Job ID: 423710
Key Responsibilities:
- Work with Global Regulatory Leads (GRL), Regulatory Matrix Teams (RMT), and Local Regulatory Contacts to ensure compliant submissions.
- Manage end-to-end regulatory submissions (renewals, variations, PBRERs, label harmonization).
- Conduct scenario planning for accelerated regulatory strategies.
- Liaise with Regulatory Agencies to resolve submission issues.
- Maintain project timelines and ensure compliance with GSK SOPs & global regulations.
Why Join GSK?
- Career Growth: Lead key regulatory activities in a global biopharma leader.
- Impact: Contribute to life-saving medicines & vaccines.
- Inclusive Culture: Supportive environment with diversity & well-being focus.
Eligibility & Qualifications
Basic Requirements:
✅ Bachelor’s/Master’s in Biological/Healthcare Sciences
✅ Regulatory Affairs experience in pharma R&D (drug development lifecycle)
✅ Knowledge of pre-IND through Phase IV regulatory processes
✅ Advanced English proficiency
✅ Strong project management & communication skills
Preferred Skills:
✔ Regulatory submission expertise (FDA/EMA/other agencies)
✔ Pharma project management experience
✔ Ability to work in a matrixed, global team
Benefits at GSK
- Competitive salary & bonuses
- Health & wellness programs
- Flexible work policies
- Career development & training
- Inclusive workplace initiatives
How to Apply
