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The Regulatory Specialist CMC Renewals job at GSK is an excellent opportunity for professionals with experience in regulatory affairs, CMC documentation, and pharmaceutical submissions. This role focuses on ensuring compliance, quality, and timely delivery of regulatory dossiers for pharma and vaccine products across global markets.
If you have 1โ2 years of regulatory experience and knowledge of ICH CTD documentation, this role offers strong career growth in a globally recognized biopharma company.
Key Responsibilities โ Regulatory Affairs CMC Role
- Manage multiple CMC (Chemistry, Manufacturing & Controls) renewals assignments
- Author, compile, and review regulatory submission dossiers
- Respond to queries from regulatory authorities
- Define and implement regulatory strategies for global submissions
- Perform data assessment and risk identification in submission packages
- Monitor regulatory intelligence and update compliance strategies
- Collaborate with Global Manufacturing & Supply teams
- Ensure adherence to international regulatory guidelines and policies
- Support digital transformation initiatives and tools like Veeva Vault
- Maintain accuracy, consistency, and completeness in documentation
Eligibility Criteria / Qualifications
Educational Qualification
- Bachelorโs degree in:
- Life Sciences
- Pharmacy / Chemistry
- Health Sciences or related fields
Experience Required
- 1โ2 years experience in Regulatory Affairs (CMC preferred)
- Knowledge of:
- ICH CTD documentation
- Post-approval CMC regulatory procedures
- Pharmaceutical development & manufacturing processes
Key Skills
- Strong communication and documentation skills
- Regulatory compliance understanding
- Analytical thinking & problem-solving ability
- Time management and multitasking
- Digital mindset and adaptability
Preferred Skills
- Experience with Veeva Vault
- Exposure to global regulatory submissions
- Understanding of regulatory intelligence systems
Salary & Benefits (India Estimate)
- Estimated Salary: โน6 LPA โ โน12 LPA (based on experience & market standards)
- Hybrid working model (2โ3 days office)
- Flexible working hours
- Medical insurance & life insurance
- Annual bonus & performance rewards
- Learning & development opportunities
- Global exposure in regulatory affairs
Job Location
- Bengaluru, India (Hybrid)
- Also available across global locations (Poland, Egypt, Warsaw)
Why Choose This Regulatory Affairs Job at GSK?
- Work with a top global biopharma company
- Exposure to international regulatory submissions
- Strong learning curve in CMC renewals and global compliance
- Opportunity to work on vaccines and specialty medicines
- Collaborative and innovation-driven work culture
How to Apply
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