Job Summary

You will lead planning, compilation and delivery of regulatory submission dossiers for lifecycle activities. You will coordinate with global submission teams, clinical, CMC (Chemistry, Manufacturing and Controls), quality, publishing and local regulatory partners. We value organised, collaborative people who communicate clearly and focus on practical solutions. This role offers visible impact on patient access, clear growth opportunities, and aligns with GSK's mission of uniting science, technology and talent to get ahead of disease together. This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following:

- Plan, compile and deliver high-quality electronic and paper regulatory dossiers within agreed timelines.
- Coordinate cross-functional inputs from clinical, CMC, quality, safety and commercial colleagues to complete submissions.
- Build, validate and quality-check electronic submission packages and resolve technical validation issues.
- Maintain submission trackers, version control and milestone plans to ensure transparency and audit readiness.
- Prepare responses to regulatory authority questions and support regulatory meetings when required.
- Identify and implement process improvements, coach colleagues and share best practice.

Why you: This role is hybrid. You will work on-site 2-3 days per week and remotely for the remaining days, as agreed with your manager. Basic qualification: We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor's degree in life sciences, pharmacy, chemistry, regulatory affairs or a related discipline, or equivalent experience.
- Minimum 3 years experience in regulatory affairs, submission management,



publishing or lifecycle maintenance in the pharmaceutical or clinical research environment.
- Practical experience compiling regulatory dossiers and managing submission timelines for investigational or marketed activities.
- Experience preparing electronic submissions and familiarity with eCTD principles or equivalent electronic submission practices.
- Strong written and verbal communication skills in English; able to present clear updates to stakeholders.
- Solid organisational skills, attention to detail and ability to manage competing priorities under deadlines.

Preferred Qualification

If you have the following characteristics, it would be a plus:
- Experience with regulatory content or information management systems such as Veeva Vault or similar platforms.
- Experience with CMC content, Module 1 preparation or local language submission requirements.
- Experience supporting regulatory authority interactions and preparing authority responses.
- Practical knowledge of market regulatory requirements.
- Experience working in a global, matrix environment and coordinating third-party service providers.
- Acting as single point of contact for submissions.

You make evidence-based decisions and raise issues early. You balance pace with rigour and focus on quality. You build strong working relationships and share learning. You bring a growth mindset and a willingness to coach others. You will help improve patient access through regulatory excellence.

Skills

- Regulatory Strategies
- Agile Planning
- Change Management
- Digital Fluency
- Learning Agility
- Problem Solving
- Business Acumen

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Regulatory Submission Lead (Bengaluru)
🏢 GSK India
📍 Bengaluru