Job Requirements

• Job Title: Regulatory Affair Executive
• Location: Kashmik Formulation - Sanand, Gujarat
• Qualification: BPharm
• Work Experience: 2 to 4 Years

Job Description

• Prepare, compile, and submit regulatory dossiers (CTD/ACTD/eCTD) for product registrations, renewals, and variations in domestic and export markets.
• Coordinate with regulatory authorities such as the Food and Drug Administration, European Medicines Agency, and Central Drugs Standard Control Organization for submissions, approvals, and compliance matters.
• Review product dossiers including formulation details, specifications, stability data, and validation reports to ensure regulatory compliance.
• Prepare and submit responses to deficiency letters, queries, and regulatory observations within defined timelines.
• Manage post-approval changes, variations, renewals, and lifecycle management activities.
• Review labeling, packaging artwork, and promotional materials to ensure alignment with regulatory requirements.

Take this opportunity to join Kashmik Formulation, Sanand,, as an Regulatory Affair Executive in Sanand, Gujarat, and build a successful career in the healthcare industry. Apply today for this job opportunity and grow with a leading healthcare organization.