Sun Pharma Hiring Regulatory Affairs Executive

Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.

Post : Executive - Regulatory Affairs

Job Description
• Review all data and documents related to product registrations for various health authorities.
• Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
• Prepare responses to deficiency letters received from various agencies.
• Maintain life-cycle / post approval changes for drug product registration dossiers.
• Provide regulatory support to cross functional departments.
• Prepare and submit scientific advice to various health authorities.
• eCTD compilation, verification and submission through electronic gateway
• Review, preparation and submission of annual reports to US FDA
• Review, preparation and submission of post approval supplements to US FDA
• Reviewing of the plant change control and established the variation strategy for submission
• Review of query response prepared and compiled by regulatory associates
• Review of all the documents received from stake holder for dossier compilation, Query response and Life cycle management
• Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities

Additional Information
Experience : 4-8 years
Qualification : M.Pharm
Location : Baroda
Job Grade : G12A Executive
Industry Type : Pharma / Healthcare / Clinical research
Business Unit : R&D1 Regulatory Affairs
End Date : 30th September 2026