GSK Hiring Regulatory Specialist (CMC)
- GSK Hiring Regulatory Specialist (CMC) | 2+ Years Experience | Bengaluru (Hybrid)
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities
- Eligibility & Qualifications
- Educational Qualification
- Experience
- Preferred Qualifications
- Required Skills
- Location & Working Model
- Career Growth Opportunities
- Application Process
- Frequently Asked Questions (FAQs)
- 1. Is this role suitable for freshers?
- 2. What type of regulatory work is involved?
- 3. Is this a remote position?
- 4. Is experience in CTD/eCTD mandatory?
- 5. Does the role involve global exposure?
- Summary Table
GSK Hiring Regulatory Specialist (CMC) | 2+ Years Experience | Bengaluru (Hybrid)
GSK is hiring a Regulatory Specialist in the Regulatory Affairs department at its Bengaluru location. This is a full-time hybrid opportunity for professionals with a minimum of 2 years of CMC regulatory experience in the pharmaceutical industry. The role focuses on CMC Annual Reports, global post-approval regulatory compliance, and worldwide submission support for Pharma (Rx) and Vaccine (Vx) portfolios.
If you are looking to strengthen your career in global regulatory affairs, CMC documentation, NDA/BLA lifecycle management, and international regulatory submissions, this opportunity offers strong exposure within a globally recognized biopharma organization.
Company Overview
entity[“organization”,”GSK”,”biopharma company”] is a global biopharma company focused on uniting science, technology, and talent to get ahead of disease together. The organization operates across multiple therapeutic areas including oncology, immunology, respiratory diseases, infectious diseases, and HIV. With a strong R&D-driven approach and global regulatory footprint, GSK supports millions of patients worldwide through innovative medicines and vaccines.
The company combines regulatory science, digital transformation, and manufacturing excellence to maintain compliance across major markets including the US, EU, Canada, Brazil, and China. Its regulatory teams play a critical role in ensuring product quality, safety, and uninterrupted supply.
Job Role & Responsibilities
The Regulatory Specialist will primarily focus on CMC (Chemistry, Manufacturing and Controls) Annual Reporting and post-approval regulatory activities for global markets.
Key Responsibilities
- Plan, prepare, technically review, and deliver CMC Annual Reports for NDAs (New Drug Applications), BLAs (Biologics License Applications), DMFs (Drug Master Files), Canadian Annual Notifications, and Brazil/China CMC Annual Reports.
- Ensure compliance with global post-approval regulatory requirements.
- Prepare high-quality regulatory documentation aligned with worldwide agency guidelines.
- Collaborate with Local Operating Companies (LOCs), manufacturing sites, Product Owners, Submission Leads, and cross-functional regulatory teams.
- Monitor global regulatory intelligence and proactively address regulatory changes.
- Manage multiple regulatory submissions while ensuring accuracy, completeness, and on-time delivery.
- Identify process improvements to enhance submission efficiency and quality standards.
- Contribute to digital capability enhancement within regulatory workflows.
- Support knowledge sharing, mentoring, and training activities where required.
This role requires strong expertise in global regulatory submissions, CMC lifecycle management, and post-approval variation management.
Eligibility & Qualifications
Educational Qualification
Bachelor’s degree in:
Life Sciences, Pharmacy, Pharmaceutical Sciences, Chemistry, Health Sciences, Biotechnology, Microbiology, Biochemistry, or related disciplines.
Experience
- Minimum 2 years of experience in CMC regulatory affairs.
- Experience in pharmaceutical regulatory submissions and post-approval activities.
- Knowledge of global CMC post-approval regulatory requirements.
Preferred Qualifications
- Experience with CTD/eCTD documentation and global submission formats.
- Understanding of drug development, manufacturing, and supply chain processes.
- Exposure to NDA, BLA, and DMF documentation.
Required Skills
- Strong analytical and organizational skills.
- Excellent attention to detail and regulatory accuracy.
- Effective communication and stakeholder collaboration skills.
- Ability to manage multiple projects simultaneously.
- Fluent English communication (written and spoken).
Location & Working Model
- Location: Bengaluru, India
- Work Model: Hybrid
- Employment Type: Full Time
- Job ID: 435916
GSK offers competitive compensation, annual performance-based bonuses, healthcare and wellbeing programs, learning and development opportunities, and structured career growth pathways within regulatory affairs and global submissions.
Career Growth Opportunities
Professionals in this role can progress toward:
- Senior Regulatory Affairs Specialist
- CMC Regulatory Lead
- Global Submission Manager
- Regulatory Strategy Manager
- Regulatory Operations Lead
Exposure to multi-market regulatory frameworks strengthens long-term career prospects in global regulatory consulting, submission leadership, and regulatory strategy.
Application Process
Interested candidates can apply through GSK’s official careers portal using the link below:
https://jobs.gsk.com/en-gb/jobs/435916?lang=en-us&source=LinkedIn
Applicants should highlight CMC regulatory experience, CTD/eCTD exposure, post-approval submission expertise, and cross-functional collaboration skills in their resume.
Frequently Asked Questions (FAQs)
1. Is this role suitable for freshers?
No. A minimum of 2 years of CMC regulatory experience is required.
2. What type of regulatory work is involved?
The role focuses on CMC Annual Reports, NDA/BLA/DMF submissions, and global post-approval regulatory compliance.
3. Is this a remote position?
No. It follows a hybrid working model based in Bengaluru.
4. Is experience in CTD/eCTD mandatory?
It is preferred but not explicitly mandatory; however, it significantly strengthens eligibility.
5. Does the role involve global exposure?
Yes. The role supports regulatory submissions across multiple international markets.
Summary Table
| Company | GSK |
| Vacancies | Regulatory Specialist (CMC Annual Reporting) |
| Required Education | BSc/MSc Life Sciences, Pharmacy, Chemistry, Biotechnology, Health Sciences |
| Experience | Minimum 2 years in CMC Regulatory Affairs |
To apply for this job please visit jobs.gsk.com.
