Apply Online for Regulatory Affairs Manager at GSK

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Post : Manager - Regulatory Affairs (Clinical Trails)

Job Description
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 appropriate actions.
• Ensure adherence to company SOPs and processes, regulatory procedures, and documentation standards.

Candidate Profile
A. Educational Background
Minimum Level of Education: Bachelor's degree
Area of Specialisation: Life Sciences/Pharmacy
B. Job-Related Experience
Minimum Level of Job-Related Experience required : 8-10 years

Additional Information
Experience : 8-10 years
Qualification : Bachelor's degree Life Sciences/Pharmacy
Location : Worli Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : DRA
End Date : 30th September 2026