GSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver £40 billion in annual sales, leveraging our existing robust performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems.
Our diverse portfolio consists of vaccines, specialty medicines, and general medicines.
Through continuous innovation and a dedicated focus on scientific and technical excellence, we strive to develop and launch new, groundbreaking treatments that address critical health challenges.
Position Summary
To support business objectives in efficient ways and in compliance with local legislation. Support Senior Manager to achieve India targets for submissions, approvals and LCM activities for the assigned products and also play a critical role in developing and implementing plan and working procedure of the department.
Responsibilities
- Project lead for assigned products for end to end management of regulatory submissions to CDSCO/DCGI for pharmaceutical, biopharmaceutical, and vaccine products for clinical trial applications and life cycle management for clinical studies.
- Ensure compliance with applicable Indian regulations, including the NDCT Rule 2019, Drugs & Cosmetics Act 1940 and Rules 1945, CDSCO requirements, and relevant regulatory guidelines.
- Liaise with Global Regulatory Affairs, Medical, Clinical and Pharmacovigilance teams to obtain required documentation and ensure successful submissions.
- Maintain and manage regulatory information, submissions, and lifecycle activities through regulatory databases and KPIs within Veeva Vault and associated regulatory tracking systems.
- Evaluate regulatory intelligence for potential business risks, compliance impacts, and opportunities, and recommend appropr