Biocon is hiring a Consultant for Regulatory Affairs and Regulatory Publishing in Bengaluru. This opportunity is suitable for candidates with 1–2 years of experience who have knowledge of eCTD, NeeS submissions, ICH guidelines and electronic regulatory dossier publishing.

The selected candidate will support the preparation, compilation, validation and submission of electronic regulatory dossiers to global health authorities. The position involves end-to-end eCTD publishing, document-level publishing, lifecycle management and quality control of regulatory submissions.

Candidates with hands-on exposure to Lorenz DocuBridge, eCTD Validator, ISI Toolbox, Adobe Acrobat, Microsoft Excel and SharePoint may be particularly relevant for this Biocon Regulatory Affairs job.

Job Overview

Key Responsibilities

Candidates selected for the Biocon Regulatory Affairs Consultant job may be responsible for:

• Preparing high-quality electronic regulatory submissions, including eCTD and NeeS dossiers.
• Performing end-to-end eCTD submission activities.
• Conducting document-level regulatory publishing and dossier compilation.
• Dispatching regulatory submissions to relevant health authorities across developed and Rest of World (ROW) markets.
• Managing regulatory lifecycle submissions, including variations, amendments and renewals.
• Performing document-level publishing, hyperlinking and bookmarking.
• Validating electronic regulatory submission packages before dispatch.
• Conducting quality-control checks to ensure submission readiness and regulatory compliance.
• Working with publishing platforms and regulatory systems such as Lorenz DocuBridge, eCTD Validator and ISI Toolbox.
• Using Adobe Acrobat, Microsoft Excel and SharePoint for documentation and submission-related activities.
• Collaborating with Regulatory Affairs, CMC, Clinical and other cross-functional teams.
• Maintaining awareness of applicable ICH, FDA and EMA regulatory guidelines.

Qualification and Eligibility

According to the provided Biocon job listing:

Educational Qualification: Any Graduate

Experience: 1–2 years

Although the listing specifies Any Graduate, candidates should have relevant regulatory publishing knowledge and experience appropriate to the position.

Candidates from pharmacy, pharmaceutical sciences and life-science backgrounds who meet the required professional experience may find the role particularly aligned with their domain knowledge; however, this should not be interpreted as an employer-stated restriction on eligible degrees.

Skills Required

Applicants should ideally have knowledge or hands-on experience in:

• eCTD submissions
• NeeS submissions
• Regulatory publishing
• Electronic dossier compilation
• Document-level publishing
• Submission lifecycle management
• Hyperlinking and bookmarking
• Regulatory submission validation
• Quality control
• ICH guidelines
• FDA and EMA requirements
• Lorenz DocuBridge
• eCTD Validator
• ISI Toolbox
• Adobe Acrobat
• Microsoft Excel
• SharePoint

Strong attention to detail and the ability to collaborate effectively with cross-functional teams are also important for this regulatory publishing position.

What Is eCTD Regulatory Publishing?

The Electronic Common Technical Document (eCTD) is a structured electronic format used for regulatory submissions to health authorities. Regulatory publishing professionals help transform regulatory documents into submission-ready electronic dossiers that meet technical and agency-specific requirements.

In this Biocon role, the Consultant will work on activities such as document publishing, dossier compilation, validation, quality control and lifecycle submissions.

This makes the opportunity particularly relevant for professionals seeking to develop their careers in Regulatory Affairs, Regulatory Operations, eCTD Publishing and Regulatory Submission Management.

Why Consider This Biocon Opportunity?

The role provides exposure to important areas of global regulatory operations, including:

• Global electronic regulatory submissions
• eCTD and NeeS publishing
• Developed and ROW market submissions
• Regulatory lifecycle management
• International regulatory guidelines
• Cross-functional collaboration with Regulatory Affairs, CMC and Clinical teams
• Specialized regulatory publishing software

For professionals already working in regulatory operations or publishing, the position can provide further experience in global submission processes.

Salary

Biocon has not disclosed the salary for this position in the supplied job advertisement.

For structured-data purposes only, PharmaBharat may use an editorially estimated market range of approximately ₹4,00,000–₹7,00,000 per year for a Bengaluru regulatory publishing professional with 1–2 years of relevant experience.

Important: This is an estimated range and is not an official salary commitment from Biocon. Actual compensation may differ depending on experience, skills, internal salary structure and the final offer.

How to Apply

Application Link