Regulatory Specialist Job at GSK for CTA IND submissions in Bengaluru and Mumbai. Regulatory affairs professionals with 2–5 years experience apply.
Company Overview
GSK (GlaxoSmithKline) is a globally recognized biopharmaceutical company focused on improving human health through innovative medicines, vaccines, and scientific research. With operations spanning across multiple countries, GSK is committed to developing advanced treatments that address some of the world’s most challenging diseases.
The company’s research and development strategy combines scientific expertise, advanced technology, and a deep understanding of the immune system to accelerate the discovery of new therapies. GSK operates across key therapeutic areas including respiratory diseases, oncology, immunology, HIV, and infectious diseases, helping millions of patients worldwide.
GSK has announced a career opportunity for the role of Regulatory Specialist-II – CTA/IND Development Delivery at its India operations in Bengaluru and Mumbai. This role is designed for regulatory affairs professionals who have experience in clinical trial submissions and early-stage regulatory dossier preparation. Regulatory Specialist Job at GSK
Job Overview
| Job Title | Regulatory Specialist-II – CTA/IND Development Delivery |
|---|---|
| Company | GSK (GlaxoSmithKline) |
| Department | Regulatory Affairs |
| Job Location | Bengaluru / Mumbai, India |
| Employment Type | Full-Time |
| Experience Required | 2 – 5 Years |
| Qualification | Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field |
| Industry | Biopharmaceutical / Regulatory Affairs |
| Application Mode | Online Application |
Job Location & Employment Type
The selected candidate will work at GSK’s offices in Bengaluru or Mumbai (Worli). The role primarily involves working with global regulatory teams and supporting regulatory submissions related to clinical trial applications.
This is a full-time position within the Regulatory Affairs department. The role may include occasional hybrid work flexibility depending on business requirements and collaboration with global teams across different time zones. Regulatory Specialist Job at GSK
Open Position / Department Details
Regulatory Specialist-II – CTA/IND Development Delivery
The Regulatory Specialist-II will support the preparation and submission of regulatory dossiers for Clinical Trial Applications (CTA) and Investigational New Drug (IND) submissions. This role involves coordinating with cross-functional teams such as clinical, CMC, quality, and external partners to ensure regulatory documentation is accurate and submitted within required timelines.
Professionals working in this role will gain valuable experience in regulatory systems, submission processes, and regulatory strategy development for clinical-stage pharmaceutical products. Regulatory Specialist Job at GSK
Key Roles & Responsibilities
The Regulatory Specialist-II will contribute to several regulatory operations activities related to clinical trial submissions and regulatory documentation. Regulatory Specialist Job at GSK
Key responsibilities include:
- Compiling, formatting, and delivering CTA and IND regulatory dossiers according to regulatory strategy and submission timelines
- Coordinating document collection from clinical, CMC, quality, and external partners
- Performing quality checks on submission documents to ensure regulatory compliance
- Maintaining regulatory submission records in regulatory management systems
- Conducting routine data verification and tracking submission status
- Supporting responses to queries raised by regulatory authorities
- Preparing regulatory correspondence and supporting documentation
- Identifying potential risks or missing information that could affect submission timelines
- Communicating status updates to project teams and cross-functional stakeholders
- Contributing to process improvements and regulatory system testing activities
- Assisting with development of guidance documents and work instructions for regulatory teams
Eligibility Criteria
Candidates interested in applying for this opportunity should meet the following requirements. Regulatory Specialist Job at GSK
Education
Applicants should possess a Bachelor’s degree in one of the following fields:
- Life Sciences
- Pharmacy
- Chemistry
- Related scientific disciplines
A postgraduate degree or certification in regulatory affairs may be considered an advantage.
Experience
- Minimum 2 to 5 years of experience in Regulatory Affairs or Regulatory Operations
- Experience working with clinical trial submissions or early-phase regulatory dossiers
Skills Required
Candidates applying for this role should ideally have:
- Practical knowledge of CTA and IND regulatory submission processes
- Experience working with regulatory document management systems
- Understanding of regulatory requirements for clinical development programs
- Strong documentation and data management skills
- Good communication and coordination skills when working with global teams
- Proficiency in Microsoft Office tools and regulatory submission systems
Preferred Qualifications
The following additional qualifications will be considered advantageous:
- Experience with electronic submission systems such as Veeva Vault
- Familiarity with eCTD publishing or non-eCTD dossier structures
- Understanding of CMC and clinical documentation requirements for early-phase submissions
- Experience in regulatory information management systems
- Prior work experience in regulated industries such as clinical research or pharmaceutical manufacturing
- Postgraduate degree or professional certification in regulatory affairs
Salary & Benefits
Compensation and benefits for this role will be as per company norms, based on the candidate’s qualifications and professional experience. Regulatory Specialist Job at GSK
Additional Benefits
Employees working at GSK may receive:
- Opportunities for career development and professional training
- Exposure to global regulatory frameworks and clinical development processes
- Collaboration with international teams and regulatory experts
- Inclusive workplace culture promoting diversity and professional growth
- Opportunity to contribute to innovative therapies and vaccines
Selection Process
The recruitment process for this role may involve the following steps:
- Online application submission
- Resume screening and candidate shortlisting
- HR discussion with shortlisted candidates
- Technical interview focusing on regulatory affairs knowledge
- Final evaluation and candidate selection
Candidates who successfully complete the interview process may receive further instructions regarding onboarding. Regulatory Specialist Job at GSK
How to Apply
Interested candidates who meet the eligibility criteria can apply for this opportunity through the GSK official careers portal.
Applicants are encouraged to submit an updated resume highlighting their experience in regulatory submissions, clinical trial documentation, and regulatory operations. Regulatory Specialist Job at GSK
Important Dates
| Event | Date |
|---|---|
| Application Deadline | 19 March 2026 |
Candidates should apply before the deadline to ensure their application is considered.
Why Apply for This Pharma Job?
This role offers an excellent opportunity for regulatory affairs professionals to work with one of the world’s leading biopharmaceutical companies. Professionals joining GSK will gain exposure to global regulatory submission processes, clinical development programs, and innovative therapies.
Working within a multinational regulatory team allows professionals to develop advanced expertise in regulatory strategy, dossier preparation, and regulatory systems while contributing to patient-focused scientific advancements. Regulatory Specialist Job at GSK
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical and life sciences career opportunities for informational purposes only. We are not affiliated with GSK or any organization mentioned in this post.
Applicants are advised to verify all job details directly with the company before submitting applications or sharing personal information. Regulatory Specialist Job at GSK
Final Call-to-Action
Professionals with experience in regulatory submissions and clinical trial documentation are encouraged to apply for this opportunity. If you meet the eligibility criteria and are interested in advancing your career in global regulatory affairs, consider applying for the Regulatory Specialist-II role at GSK. Regulatory Specialist Job at GSK
