Sun Pharmaceutical Industries Ltd is hiring for an Executive – Regulatory Affairs – EM Market position at its Gurgaon R&D location. The role focuses on regulatory submissions, CMC dossier preparation, responses to regulatory queries, lifecycle management and regulatory compliance for WHO and Sub-Saharan Africa markets.

The position involves working with cross-functional stakeholders and preparing regulatory documentation to support timely product approvals and post-approval activities.

Sun Pharma’s current Gurgaon R&D regulatory postings similarly cover dossier preparation, deficiency responses, post-approval changes and regulatory support, demonstrating the type of regulatory work undertaken within its R&D organization.

Job Overview

Key Responsibilities

1. New Regulatory Submissions

The Executive will support preparation and review of regulatory documentation for new product submissions, including:

• Reviewing and preparing CMC (Chemistry, Manufacturing and Controls) dossiers.
• Reviewing development reports and scale-up reports.
• Reviewing product specifications and stability protocols.
• Reviewing artworks and related documentation.
• Assessing documentation before initiation of exhibit batches.

2. Regulatory Approvals

The role includes supporting regulatory approval activities by:

• Reviewing regulatory agency deficiency letters and queries.
• Preparing responses to regulatory deficiencies.
• Coordinating information required for responses.
• Supporting timely approval of submitted products.

3. Regulatory Lifecycle Management

The Executive will support lifecycle management of pharmaceutical formulations by:

• Preparing and reviewing variations according to country-specific requirements.
• Supporting changes involving API vendors, ROS/test parameters and drug-product manufacturing sites.
• Supporting product harmonization activities.
• Preparing and reviewing re-registration and PCH dossiers.
• Submitting relevant dossiers to regional offices and regulatory agencies.

4. Regulatory Compliance

Responsibilities also include:

• Preparing, reviewing and circulating approval packages to relevant stakeholders.
• Updating approval packages based on regulatory queries and variations.
• Maintaining comprehensive product information in the central repository.
• Reviewing the regulatory filing impact of variations and change controls.
• Supporting accurate regulatory documentation and compliance activities.

Skills Required

Candidates interested in Regulatory Affairs jobs at Sun Pharma should have knowledge or experience relevant to:

• Regulatory Affairs
• CMC Dossier Preparation
• Regulatory Submissions
• Emerging Markets Regulatory Affairs
• Lifecycle Management
• Variations
• Regulatory Compliance
• Regulatory Query Responses
• Pharmaceutical Documentation
• Change Control
• Product Registration
• Pharmaceutical Formulations
• Cross-functional Collaboration

Who Can Apply?

This position is particularly relevant to professionals pursuing careers in:

• Regulatory Affairs
• Pharmaceutical R&D
• CMC Regulatory Affairs
• Product Registration
• Regulatory Submissions
• Emerging Markets Regulatory Affairs
• Lifecycle Management
• Pharmaceutical Compliance

Candidates should verify the official vacancy for the employer’s stated educational and experience requirements.

Why This Role Matters for Regulatory Affairs Professionals

The position provides exposure to several important areas of pharmaceutical regulatory operations, including new product submissions, CMC documentation, regulatory queries, variations, re-registration and lifecycle management.

The focus on WHO and Sub-Saharan Africa markets also makes the role relevant to professionals interested in emerging-market regulatory operations.

Benefits and Career Development

Sun Pharma’s current career listings describe a focus on employee development, collaboration and professional growth. Its job postings highlight opportunities to develop within the organization and work collaboratively across functions.

Specific benefits for this position were not provided in the supplied job description, so candidates should confirm the applicable benefits directly with the company.

How to Apply

Application Link