PHARMAFull-time
Manager - Regulatory Affairs (Clinical Trails)
By Admin · Regulatory Affairs
MUMBAI (IN)ONSITEPOSTED: 9/1/2026
PHARMAFull-time
HIRING ORGANIZATIONGSKPharmaceuticals / Healthcare / Life Sciences
ROLE DEFINITION & RESPONSIBILITIES
Position Summary
Support business objectives efficiently while maintaining compliance with applicable local legislation.
Support the Senior Manager in achieving India targets for regulatory submissions, approvals, and lifecycle management activities for assigned products.
Contribute to the development and implementation of departmental plans and working procedures.
Core Regulatory Responsibilities
Act as project lead for assigned products and manage end-to-end regulatory submissions to CDSCO/DCGI.
Handle regulatory activities for pharmaceutical, biopharmaceutical, and vaccine products, including clinical trial applications and lifecycle management activities for clinical studies.
Ensure compliance with applicable Indian regulatory requirements, including the New Drugs and Clinical Trials Rules (NDCT) 2019, Drugs & Cosmetics Act 1940, Drugs & Cosmetics Rules 1945, CDSCO requirements, and relevant regulatory guidelines.
Liaise with Global Regulatory Affairs, Medical, Clinical, and Pharmacovigilance teams to obtain required documentation and support successful regulatory submissions.
Maintain and manage regulatory information, submissions, and lifecycle activities through regulatory databases and KPI tracking systems, including Veeva Vault and associated regulatory tracking systems.
Evaluate regulatory intelligence to identify potential business risks, compliance impacts, and opportunities and recommend appropriate actions.
Ensure adherence to company SOPs, regulatory procedures, processes, and documentation standards.
Educational & Experience Requirements
Minimum Bachelor's degree in Life Sciences or Pharmacy.
Requires 8-10 years of relevant job-related experience.
The experience requirement is intended to enable the successful management of end-to-end drug registration procedures and regulatory maintenance actions in accordance with applicable regulations.
Functional & Professional Skills
Agile planning.
Business acumen.
Change management.
Digital fluency.
Learning agility.
Problem solving.
Regulatory strategy and strategic regulatory thinking.
End-to-end regulatory submission management.
Clinical trial regulatory affairs.
Regulatory lifecycle management.
CDSCO/DCGI interactions and Indian regulatory compliance.
Cross-functional collaboration with Global Regulatory Affairs, Medical, Clinical, and Pharmacovigilance teams.
Business & Organizational Impact
Contribute to GSK's India regulatory objectives through timely submissions, approvals, and lifecycle management.
Support regulatory strategies that enable development and maintenance of pharmaceutical, biopharmaceutical, and vaccine products.
Identify regulatory intelligence, risks, compliance implications, and business opportunities to support informed decision-making.
Help establish effective departmental procedures and working practices.
Company & Inclusion Information
GSK is a global biopharma company focused on prevention and treatment through specialty medicines and vaccines.
GSK identifies respiratory, immunology and inflammation, oncology, HIV, and infectious diseases as key therapeutic areas.
The company states its ambition to positively impact the health of 2.5 billion people by the end of the decade.
GSK promotes an inclusive recruitment environment and provides recruitment-process adjustments where required.
GSK states that it does not charge candidates any recruitment fee and warns candidates about fraudulent job advertisements and unsolicited payment requests.
Candidates receiving suspicious communications from addresses that do not end in gsk.com are advised to disregard them and verify the communication with GSK.
REQUIRED VERIFIED SKILLS
Bachelor's Degree
Life Sciences
Pharmacy
Regulatory Affairs
Clinical Trial Applications
Regulatory Submissions
CDSCO
DCGI
NDCT Rules 2019
Drugs & Cosmetics Act 1940
Drugs & Cosmetics Rules 1945
Indian Regulatory Guidelines
Drug Registration
Lifecycle Management
Veeva Vault
Regulatory Databases
KPI Tracking
SOP Compliance
Regulatory Intelligence
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
No salary range, bonus amount, or specific compensation figures are disclosed in the provided posting. Because this is a Manager-level role requiring 8-10 years of relevant experience and specialized Indian regulatory expertise, compensation should be evaluated against senior Regulatory Affairs market levels in Mumbai and the broader pharmaceutical/biopharmaceutical sector. Candidates should confirm base salary, performance incentives, benefits, retirement contributions, insurance, and other GSK total-reward components directly during the recruitment process.
ORGANIZATION CONTEXT & CULTURE
GSK (GlaxoSmithKline) is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. The company focuses on the research, development, and manufacture of innovative vaccines and specialty medicines. GSK's products address a wide range of diseases, aiming to impact the health of millions worldwide.
TEAM SIZE: 70,000+ employees
INDUSTRY: Pharmaceuticals / Healthcare / Life Sciences
EXPECTED CAREER ROADMAP
This Manager-level Regulatory Affairs role offers progression toward Senior Manager and broader regulatory leadership positions. The position provides substantial exposure to end-to-end clinical trial submissions, drug registration, lifecycle management, CDSCO/DCGI regulatory interactions, regulatory strategy, regulatory intelligence, and cross-functional work with global and local stakeholders. With continued experience, candidates can progress into senior regulatory leadership, regional/global regulatory strategy, portfolio regulatory management, or specialized regulatory consulting and governance roles within the biopharmaceutical industry.
APPLICATION ADVISORY
Highlight 8-10 years of Regulatory Affairs experience and a Bachelor's degree in Life Sciences or Pharmacy prominently. Emphasize hands-on experience with CDSCO/DCGI submissions, clinical trial applications, drug registration, lifecycle management, NDCT Rules 2019, Drugs & Cosmetics Act/Rules, and Indian regulatory guidelines. Clearly demonstrate experience leading end-to-end submissions and coordinating with Global Regulatory Affairs, Medical, Clinical, and Pharmacovigilance functions. Mention Veeva Vault or comparable regulatory information-management systems, KPI tracking, regulatory intelligence, risk assessment, SOP compliance, and regulatory strategy. Prepare examples showing how you managed submission timelines, addressed regulatory risks, interpreted new regulations, and supported approvals or lifecycle activities. Verify all application communications and avoid any request for recruitment payments, as GSK explicitly states that it does not charge recruitment fees.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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