Sun Pharma Hiring Executive – Regulatory Affairs

Regulatory Affairs Executive – Baroda | Sun Pharma

Sun Pharma hiring Executive – Regulatory Affairs (R&D) in Baroda. M.Pharm/M.Sc with 1–4 years experience. Apply online.

Sun Pharmaceutical Industries Ltd is inviting applications for the role of Executive – Regulatory Affairs at its R&D facility in Tandalja, Baroda. This opportunity is designed for regulatory professionals who want to work on global pharmaceutical dossiers and lifecycle management for regulated international markets. The role offers direct exposure to regulatory strategy, CMC documentation, and approvals across key MENA geographies within India’s largest pharmaceutical organization.

Company Overview

Sun Pharmaceutical Industries Ltd is India’s No.1 pharmaceutical company and a leading global specialty generics organization with a presence in more than 100 countries. Known for its strong R&D capabilities, regulatory compliance, and robust quality systems, Sun Pharma operates multiple USFDA, EMA, and WHO-GMP approved facilities. The company’s regulatory teams play a critical role in ensuring timely product approvals, lifecycle compliance, and global market expansion.

Job Role & Responsibilities

Regulatory Submissions & Approvals

• Preparation and review of CMC dossiers for new product submissions and renewals
• Regulatory filing support for fresh submissions, renewals, and variations
• Preparation and response to regulatory deficiency queries to enable product approvals

Lifecycle Management

• Handling post-approval changes including API vendor changes, ROS updates, test parameter changes, and dosage form site changes
• Preparation and review of variations as per country-specific regulatory requirements
• Harmonization of product dossiers across multiple markets

Regulatory Compliance & Documentation

• Review of development reports, scale-up reports, specifications, stability protocols, and artwork prior to exhibit batch initiation
• Circulation of approval packages and product history sheets to internal stakeholders
• Maintenance of comprehensive regulatory documentation in central repositories
• Assessment of regulatory impact for change controls and variations

Market Scope

• Regulatory activities focused on MENA markets including GCC, UAE, Saudi Arabia, Oman, Egypt, Iran, Iraq, and Bahrain

Eligibility / Qualifications

Educational Qualification

• M.Sc, M.Pharm

Experience

• 1 to 4 years of experience in pharmaceutical regulatory affairs
• Exposure to CMC documentation and lifecycle management preferred
• Experience in international regulatory submissions is an advantage

Relevant Courses: M.Pharm (Pharmaceutics, Pharmaceutical Technology, Quality Assurance), M.Sc Chemistry, M.Sc Pharmaceutical Sciences

Location & Salary

• Location: Tandalja (R&D), Baroda, Gujarat
• Salary: As per industry standards and experience (not disclosed)

Application Process

Interested candidates can apply online through the official Sun Pharma careers portal:

👉 https://careers.sunpharma.com/job/Baroda-Executive-Regulatory-Affairs/46936944/

Early applications are encouraged due to high competition for regulatory affairs roles in global pharmaceutical companies.

Frequently Asked Questions (FAQs)

Q1. Is this role suitable for M.Pharm freshers?
No. This position requires 1–4 years of regulatory affairs experience.

Q2. Which markets will I work on in this role?
You will handle regulatory submissions and lifecycle management for MENA markets including GCC countries.

Q3. Is prior international regulatory exposure mandatory?
It is preferred but not mandatory. Strong CMC documentation experience is essential.

Q4. Is this a manufacturing or corporate role?
This is an R&D Regulatory Affairs role focused on dossier preparation and lifecycle compliance.

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Job Summary

Company	Sun Pharmaceutical Industries Ltd
Vacancies	Not Disclosed
Required Education	M.Sc, M.Pharm
Experience	1–4 Years