Sun Pharma Job Alert Executive – Regulatory Affairs (M.Pharm/M.Sc) for MENA Markets

Sun Pharma, India’s largest pharmaceutical company and a global leader in specialty medicines, is inviting applications for the position of Executive – Regulatory Affairs to manage regulatory compliance for its drug formulations in the MENA-GCC market.

Detail	Information
Company	Sun Pharma
Post Name	Executive – Regulatory Affairs
Location	Baroda, Gujarat
Experience Required	1-4 years
Essential Qualification	M.Sc / M.Pharm
Geographic Scope	MENA-GCC (UAE, Oman, Saudi Arabia, Egypt, Iran, Iraq, Bahrain, etc.)
Application End Date	October 20, 2025

💼 Key Job Responsibilities

The Executive will be responsible for end-to-end regulatory affairs management for drug formulations, focusing on the Middle East and North Africa (MENA) region.

1. New Submissions / Renewals:

Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh product submissions.
Review critical documents (Development report, stability protocol, etc.) and artworks for adequacy before initiating Exhibit batches.

2. Approval Management:

Review and prepare comprehensive responses to deficiency letters from regulatory agencies to ensure timely product approval.

3. Lifecycle Management:

Prepare and review variations as per country-specific requirements to support changes such as API vendor changes, manufacturing site changes (DF site changes), and product harmonization.

4. Regulatory Compliance & Documentation:

Prepare, review, and circulate the approval package and product history sheet to stakeholders.
Ensure accurate and comprehensive product information is repositioned into a central repository.
Review the regulatory filing impact of change controls and variations.

💡 Additional Information

The role also involves the development of marketing and promotional plans to support consumer needs.
The business unit is dedicated to Regulatory Affairs within the Pharma/Healthcare/Clinical research industry type.