Senior Executive IRA

Responsibilities

• Manage all activities related to loan license applications, including new filings, renewals, and retentions.
• Handle manufacturing license applications for Gujarat locations, ensuring timely responses to regulatory queries.
• Oversee WHO-GMP applications for Gujarat and loan locations, including certificate renewals and adding new products to existing certificates.
• Support joint inspections and FDA audits for the grant or retention of manufacturing and loan licenses.
• Prepare and review export NOC, Form-29, CoPP applications, and Written Confirmation applications.
• Manage miscellaneous regulatory applications such as Free Sale Certificates and manufacturing/market standing certificates.
• Provide regulatory support to various plant locations for application submissions and approvals.

Requirements

• M.Pharm degree in Pharmacy.
• Minimum 8 years of relevant experience in Regulatory Affairs.
• Proven expertise in managing loan license and manufacturing license applications.
• Extensive experience with WHO-GMP applications and compliance.
• Familiarity with supporting FDA audits and joint inspections.

About the Company

Sun Pharmaceutical Industries Ltd is a leading global pharmaceutical company dedicated to providing high-quality medicines. We foster an environment where employees can grow, take charge of their professional journeys, and thrive within a collaborative community.