Global biopharmaceutical company GSK (GlaxoSmithKline) is hiring a Regulatory Submission Specialist (SDE-LCM) in Bengaluru, India. This opportunity is ideal for Life Sciences, Pharmacy, or Chemistry graduates with 1-3 years of experience in regulatory affairs, submission management, or pharmaceutical product registration.
The selected candidate will support global regulatory teams in preparing regulatory dossiers and submission packages using systems like Veeva Vault, ensuring compliance with global health authority regulations.
This role provides excellent exposure to global regulatory strategy, dossier preparation, regulatory intelligence, and pharmaceutical product lifecycle management.
Key Responsibilities
The Regulatory Submission Specialist at GSK will be responsible for supporting global regulatory submission activities and ensuring regulatory compliance.
Major responsibilities include:
- Support preparation and compilation of regulatory submission dossiers for global regulatory authorities.
- Coordinate with Global Regulatory Strategy teams, Local Operating Companies (LOCs), and functional teams.
- Manage regulatory deliverables including:
- CMC variations
- Therapeutic variations
- PBRER submissions
- Renewals
- Site registrations and renewals
- Tender submissions
- Compile submission packages using Veeva Vault regulatory systems.
- Ensure compliance with global health authority regulations and GSK regulatory policies.
- Provide regulatory registration requirements for manufacturing sites and partners.
- Coordinate documentation requested by health authorities and regulatory agencies.
- Monitor timelines and ensure right-first-time regulatory submissions.
- Use regulatory intelligence resources to support submission strategy.
- Maintain communication with internal stakeholders and global teams.
Required Qualifications
Candidates applying for the GSK Regulatory Submission Specialist role should meet the following requirements:
Education
- Bachelorโs degree in:
- Pharmacy
- Life Sciences
- Chemistry
- Related scientific discipline
Experience
- 1-3 years of experience in:
- Regulatory Affairs
- Regulatory Submissions
- Pharmaceutical product registration
Technical Skills
- Understanding of drug development and pharmaceutical manufacturing processes
- Knowledge of EU and ROW regulatory submission guidelines
- Experience with Veeva Vault RIM or regulatory systems (preferred)
- Knowledge of global regulatory documentation and dossier preparation
Soft Skills
- Strong attention to detail
- Excellent organizational and project management skills
- Ability to manage multiple regulatory submissions simultaneously
- Strong collaboration and communication abilities
Why Join GSK?
GSK is one of the worldโs leading biopharmaceutical companies, focused on developing vaccines and specialty medicines that impact billions of patients globally.
Employees at GSK benefit from:
- Global exposure to regulatory strategy and product lifecycle management
- Work with cutting-edge pharmaceutical innovations
- Collaborative global regulatory teams
- Strong learning and career growth opportunities
- Flexible and supportive work culture
GSK aims to impact the health of 2.5 billion people globally by the end of the decade, making it a purpose-driven workplace for healthcare professionals.
Job Details
Job Title: Regulatory Submission Specialist (SDE-LCM)
Company: GSK (GlaxoSmithKline)
Location: Bengaluru, India
Experience Required: 1-3 Years
Industry: Pharmaceutical / Regulatory Affairs
Work Mode: On-site with occasional hybrid flexibility
Salary (Estimated)
Based on industry benchmarks for regulatory roles in India:
โน6,00,000 โ โน12,00,000 per year
Salary may vary depending on experience and regulatory expertise.
How to Apply
