GSK has announced an opportunity for a Reg Publishing Submission Specialist, SDE – Publishing in Bengaluru. This position is suitable for candidates with experience in regulatory affairs, regulatory publishing, electronic regulatory submissions, submission management, and regulatory documentation.
The GSK Regulatory Publishing Specialist will support the preparation, assembly, quality review, and delivery of regulatory submission packages to global Health Authorities. Candidates with a bachelor’s or master’s degree in biological or healthcare sciences and relevant regulatory submission experience are encouraged to apply.
About the Role
As a Regulatory Publishing Submission Specialist at GSK, you will work with cross-functional teams and document authors to prepare regulatory content and deliver technically compliant submission packages.
The position requires strong knowledge of regulatory authority submission requirements, document management systems, publishing standards, and electronic regulatory submissions.
Key Job Details
| Particular | Details |
|---|---|
| Company | GSK |
| Position | Reg Publishing Submission Specialist, SDE – Publishing |
| Location | Bengaluru |
| Work Model | Hybrid |
| Employment | Full-time |
| Experience | 1–6 years |
| Requisition ID | 446399 |
| Function | Regulatory Affairs / Regulatory Publishing |
Responsibilities
The key responsibilities of the GSK Regulatory Publishing Submission Specialist include:
- Manage regulatory publishing activities and submissions to Health Authorities.
- Prepare, assemble, and deliver complex electronic regulatory submission packages.
- Advise and assist authors in preparing regulatory submission content.
- Support authors in using GSK document management systems and established procedures.
- Maintain knowledge of relevant Regulatory Authority requirements and GSK submission standards.
- Ensure regulatory documents comply with required submission formats and technical specifications.
- Independently deliver complex submission packages according to agreed timelines.
- Perform quality and compliance checks on regulatory publishing work.
- Support complex or non-routine document preparation and document management activities.
- Participate in and lead the development of regulatory publishing working practices.
- Contribute to process simplification, continuous improvement, and submission quality.
Qualifications
Candidates should have a Bachelor’s or Master’s degree in Biological Sciences, Healthcare Sciences, Pharmacy, Life Sciences, or a related discipline, or relevant Regulatory Affairs experience within a drug development environment.
GSK prefers candidates with 1–6 years of relevant experience preparing electronic regulatory submissions.
Skills Required
Candidates applying for the GSK Regulatory Publishing Specialist position should ideally have skills in:
- Regulatory Publishing
- Electronic Regulatory Submissions
- Regulatory Affairs
- Submission Management
- Regulatory Documentation
- Document Management Systems
- Health Authority Submission Requirements
- Regulatory Compliance
- Submission Quality Control
- MS Word
- MS Excel
- Adobe PDF
- SharePoint
- Complex enterprise IT tools
- Cross-functional communication
- Attention to detail
- Process improvement
Knowledge or practical exposure to eCTD/CTD publishing and electronic submission lifecycle management can also be valuable for regulatory publishing careers.
Who Can Apply?
This opportunity may be relevant for professionals currently working as:
- Regulatory Publishing Associate
- Regulatory Affairs Associate
- Regulatory Submission Specialist
- eCTD Publishing Specialist
- Regulatory Operations Associate
- Regulatory Documentation Specialist
- Submission Management Associate
Candidates should note that the job description specifically asks for 1–6 years of relevant electronic regulatory submission experience, so this is not primarily advertised as a fresher position.
Why Join GSK?
GSK is a global biopharma company working across specialty medicines and vaccines. The organization aims to positively impact the health of 2.5 billion people by the end of the decade.
This role provides an opportunity to gain experience in global regulatory publishing and Health Authority submissions while collaborating with regulatory and cross-functional teams.
Employees can also gain exposure to complex submission packages, regulatory document management, publishing standards, compliance activities, and continuous process improvement.
How to Apply
