Senior Regulatory Specialist CMC Renewals Job at GSK. Global regulatory affairs role in Bengaluru and other locations. Apply before 18 March 2026.
Regulatory Affairs professionals with expertise in post-approval CMC activities and global submission strategy now have an exciting international opportunity. A full-time opening is available for Senior Regulatory Specialist – CMC Renewals, offering exposure to global pharmaceutical and vaccine portfolios. This role is ideal for experienced regulatory professionals who want to strengthen their expertise in CMC renewals, international submissions, and digital regulatory transformation. Senior Regulatory Specialist CMC Renewals Job at GSK
Company Overview
GSK is a leading global biopharmaceutical organization focused on uniting science, technology, and talent to prevent and treat disease. The company develops innovative medicines and vaccines across key therapeutic areas including respiratory, oncology, immunology, HIV, and infectious diseases. With operations across multiple global markets, GSK places strong emphasis on regulatory excellence, quality compliance, and digital innovation within its manufacturing and supply chain functions. Senior Regulatory Specialist CMC Renewals Job at GSK
Job Location & Employment Type
- Locations:
- Bengaluru (Luxor North Tower), India
- Poznan (Grunwaldzka), Poland
- Warsaw (Rzymowskiego 53), Poland
- Cairo, Egypt
- Employment Type: Full-Time
- Work Model: Hybrid (as per location policy)
Open Position Details
Job Title: Senior Regulatory Specialist – CMC Renewals
Job Requisition ID: 436496
Application Deadline: 18 March 2026
This role is part of the Renewals CMC Team responsible for regulatory lifecycle management of pharmaceutical and vaccine products across global markets. Senior Regulatory Specialist CMC Renewals Job at GSK
Department Overview – Renewals CMC Team
The Chemistry, Manufacturing & Controls (CMC) Renewals function ensures that pharmaceutical and vaccine products continue to meet regulatory standards for safety, efficacy, and quality throughout their lifecycle. The team is responsible for preparing, reviewing, and managing renewal submissions while maintaining compliance with evolving global regulations. In addition to scientific expertise, the team actively integrates digital tools and regulatory intelligence systems to enhance efficiency. Senior Regulatory Specialist CMC Renewals Job at GSK
Key Roles & Responsibilities
The Senior Regulatory Specialist will independently manage multiple CMC renewals and regulatory submissions across international markets. Key responsibilities include:
- Managing end-to-end CMC renewal submissions for Pharma and Vaccines products
- Responding to regulatory agency queries related to renewal dossiers
- Defining and implementing regulatory strategies for assigned markets
- Reviewing and assessing CMC data to ensure compliance with company standards and global regulations
- Identifying potential submission risks and proposing mitigation strategies
- Escalating business-impacting issues with recommended solutions
- Ensuring documentation complies with ICH CTD format and global regulatory requirements
- Acting as dossier reviewer (peer review and quality checks)
- Monitoring regulatory intelligence updates and proactively implementing changes
- Collaborating with Global Manufacturing & Supply teams and local operating companies worldwide
- Participating in process improvement initiatives and regulatory system enhancements
- Serving as subject matter expert in assigned CMC domains and mentoring junior staff
- Supporting digital transformation initiatives within Regulatory Affairs
The role requires strong scientific understanding combined with strategic regulatory thinking and project coordination skills. Senior Regulatory Specialist CMC Renewals Job at GSK
Eligibility Criteria
Education
- Bachelor’s degree in Life Sciences, Chemistry, Health Sciences, or related discipline
Experience
- Minimum 3 years of experience in Regulatory Affairs within the pharmaceutical industry
- Proven exposure to post-approval CMC regulatory procedures
- Experience with ICH CTD documentation standards
- Understanding of global regulatory frameworks and drug development processes
Skills Required
- Strong knowledge of regulatory submission processes and lifecycle management
- Ability to independently manage complex regulatory assignments
- Excellent written and verbal English communication skills
- Strong analytical thinking and problem-solving ability
- Attention to detail with focus on accuracy and compliance
- Time management skills to handle multiple projects simultaneously
- Project management capability is an added advantage
- Familiarity with Veeva Vault (preferred)
- Digital fluency and openness to regulatory technology transformation
- Ability to collaborate across global, cross-functional teams
Salary & Benefits
For Poland-based hires, the annual base salary ranges from:
PLN 144,750 to PLN 241,250 (gross)
Compensation for other locations will be discussed during the recruitment process as per market standards and company policy.
Additional benefits may include:
- Performance-based bonus (as applicable)
- Private healthcare
- Life insurance
- Pension plan
- Additional paid leave
- Parental and family care leave benefits
Benefits vary by country and internal policy. Senior Regulatory Specialist CMC Renewals Job at GSK
Selection Process
The hiring process may include:
- Online application screening
- Technical and regulatory assessment
- Interview rounds with Regulatory Affairs leadership
- Final selection and offer
Candidates requiring reasonable accommodation during recruitment may contact the company recruitment team as mentioned in the official job posting. Senior Regulatory Specialist CMC Renewals Job at GSK
How to Apply
Eligible candidates should apply through the official online application portal before 18 March 2026. Ensure that your resume clearly reflects CMC regulatory experience, post-approval lifecycle management exposure, and familiarity with ICH CTD documentation standards.
Early submission is recommended due to limited application time. Senior Regulatory Specialist CMC Renewals Job at GSK
Important Dates
- Application Deadline: 18 March 2026
- Applications are currently open
Why Apply for This Pharma Regulatory Job?
CMC renewals and post-approval lifecycle management are critical functions within global pharmaceutical operations. This role offers:
- Exposure to international regulatory markets
- Opportunity to lead complex CMC renewal strategies
- Experience working with vaccines and innovative pharmaceutical products
- Involvement in digital regulatory transformation initiatives
- Career growth in global Regulatory Affairs
Professionals aiming to advance in regulatory strategy, lifecycle management, and global CMC compliance will find this position highly valuable for long-term career progression. Senior Regulatory Specialist CMC Renewals Job at GSK
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical and healthcare job updates for informational purposes only. We are not affiliated with GSK or any organization mentioned above. Applicants are advised to verify complete job details on the official company website before applying. Senior Regulatory Specialist CMC Renewals Job at GSK
Interested Regulatory Affairs professionals with relevant CMC renewals experience are encouraged to apply before the deadline to take the next step in their global regulatory career.
