Table of Contents
BSc Biotech Jobs Mumbai – GSK Jobs – Regulatory Specialist Jobs
Looking for BSc Biotech Jobs Mumbai? Global pharma leader GSK is hiring for an exciting regulatory role, offering a strong career opportunity for life science graduates aiming to work in drug development and compliance. These GSK Jobs are ideal for candidates seeking hands-on exposure to global regulatory submissions, clinical trial documentation, and investigational product management. If you are targeting long-term growth in regulatory affairs, this opening stands out among current Regulatory Specialist Jobs in India’s pharmaceutical and biotech sector.
Regulatory Specialist, SDE- Investigational
Bengaluru, India; Worli Mumbai, India
Job ID: 432245
Job description
Site Name: Bengaluru Luxor North Tower, India – Maharashtra – Worli Mumbai
Posted Date: Dec 19 2025
Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Our approach to R&D
Position Summary
This role supports regulatory management by ensuring alignment between GSK’s business objectives, strategy, and the necessary processes to meet Health Authority requirements for regulatory submissions. The Regulatory Operations Specialist will contribute to the optimization and continuous improvement of GSK’s regulatory systems and processes.
The Specialist will collaborate with stakeholders to support the prioritization and implementation of global regulatory submissions, ensuring both compliance with Health Authority requirements and alignment with GSK’s business goals. This includes execution of project timelines and maintaining communication with stakeholders.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
-
Contribute to the preparation of Clinical Trial Application (CTA) packages for EU and Non-EU regions, including Application forms and Market Specific documents, and compiling submission components (e.g., Investigator’s Brochure (IB), protocol, Investigational Medicinal Product Dossier (IMPD), etc.).
-
Support the preparation and delivery of submission packages for CTA amendments, EU End of Trial Notifications (EOTN), and EU Study Summary submissions.
-
Collaborate with project teams to assist in the planning and compilation of Development Safety Update Reports (DSURs), new US Investigational New Drug applications (INDs), and IND amendments.
-
Follow Regulatory System processes precisely and consistently, ensuring alignment with Global Regulatory Affairs (GRA) Standard Operating Procedures (SOPs), Work Instructions, and How-to Guides.
-
Maintain a patient-focused mindset while learning to identify opportunities for process efficiency and simplification.
-
Advocate for and support the use of Regulatory Systems among stakeholders and submission deliverable providers.
-
Partnering with peer colleagues in Submission Delivery Excellence and the Regulatory Asset Oversight team to maximize resources and to identify and remove barriers that will prevent a successful outcome on submission delivery targets.
-
Maintaining awareness of emerging investigational regulatory requirements across regions in scope of role.
-
Should communicate risks and issues to senior colleagues and management.
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, biotechnology, or a related scientific discipline.
-
1–4 years of experience in regulatory affairs, clinical trial applications, or a related role in the pharmaceutical or clinical research environment.
-
Has knowledge of Pharmaceutical Regulatory Affairs covering a breadth of global regulatory procedures, particularly those related to global submission requirements.
-
Good knowledge of relevant regulations and standards relating to the submission of regulatory applications and drug development worldwide.
-
Ability to coordinate the submission delivery activities as an integral member of a Regulatory Operational team.
-
Ability to work well both independently and within a team to ensure on-time delivery of objectives/projects.
-
Ability to work with and add value to matrix teams in a globally diverse organization.
Preferred Qualification
If you have the following characteristics, it would be a plus:
-
Experience with clinical trial application (CTA/IND) preparation and submissions.
-
Familiarity with regulatory information management (RIM) systems or clinical trial document repositories.
-
Understanding of global regulatory requirements across Asia or other rest-of-world markets.
-
Experience with quality systems, standard operating procedures and regulatory compliance.
-
Proactive approach to problem-solving and demonstrated ability to drive tasks to completion.
-
Prior exposure to working on lifecycle activities such as site registrations, renewals, or local variations.
CLICK HERE TO APPLY ONLINE
