GSK is hiring a Senior Regulatory Specialist – CMC Renewals to support global pharmaceutical and vaccine portfolios. This role is ideal for regulatory affairs professionals with strong expertise in Chemistry, Manufacturing and Controls (CMC), ICH CTD documentation, and post-approval regulatory procedures.
The Renewals CMC Team plays a strategic role in ensuring pharmaceutical and vaccine products remain compliant, safe, and effective across global markets. If you have 3+ years of experience in CMC regulatory affairs and want to contribute to global submissions and digital regulatory transformation, this opportunity is worth exploring.
🔎 Job Overview
Position: Senior Regulatory Specialist – CMC Renewals
Company: GSK
Job Type: Full-Time | Hybrid
Experience Required: Minimum 3 years
Department: Regulatory Affairs – CMC
This Senior Regulatory Specialist role focuses on managing complex post-approval CMC renewals, regulatory submissions, and global agency interactions for pharmaceutical and vaccine products.
📌 Key Responsibilities
As a Senior Regulatory Specialist – CMC Renewals, you will:
- Independently manage multiple CMC renewal assignments across global markets
- Define and execute regulatory strategy for CMC documentation
- Author, compile, and review ICH CTD dossiers
- Respond to regulatory authority queries
- Identify regulatory risks and propose mitigation strategies
- Serve as peer reviewer for CMC submissions
- Monitor global regulatory intelligence updates
- Support digital transformation initiatives (including Veeva Vault systems)
- Collaborate with Global Manufacturing & Supply teams and Local Operating Companies
This position demands expertise in post-approval CMC regulatory procedures, regulatory compliance, and international submission standards.
🎓 Qualifications & Skills
To qualify for this Senior Regulatory Specialist job at GSK, candidates should have:
- Bachelor’s degree in Life Sciences, Chemistry, Health Sciences, or related fields
- Minimum 3 years of experience in regulatory affairs within the pharmaceutical industry
- Strong knowledge of CMC regulatory submissions and ICH CTD documentation
- Understanding of global drug development and regulatory processes
- Excellent written and verbal English communication skills
- Strong analytical, problem-solving, and project management abilities
- Detail-oriented mindset with regulatory compliance focus
- Familiarity with Veeva Vault (preferred)
Professionals with experience in CMC renewals, global submissions, and regulatory intelligence monitoring will be highly preferred.
💼 Why Join GSK?
At GSK, you will:
- Work in a globally recognized biopharma company
- Contribute to meaningful outcomes for patients worldwide
- Be part of an inclusive and innovation-driven culture
- Gain exposure to international regulatory frameworks
- Participate in digital regulatory transformation
GSK offers competitive compensation, performance bonuses (where applicable), statutory benefits, and additional employee welfare benefits.
💰 Salary (India Market Estimate)
For the India location, the estimated annual salary range is:
₹18,00,000 – ₹28,00,000 per annum (CTC)
(Salary may vary based on experience, expertise in CMC renewals, and regulatory strategy capabilities.)
📝 How to Apply
