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
