Regulatory Affairs Analyst

• Should have an experience in Europe market pre/post approval submissions
• Evaluation of Europe post approval changes with precise classification and documentation.
• Preparation, review and submission of variations and renewals for EU market
• Timely interaction with overseas colleagues on updates/approvals
• Handling of deficiencies and timely response to regulatory agencies
• Good interpersonal skills with command on English language to communicate with Regulatory agencies & IL Customers
• Providing regulatory guidance/regulatory strategies to IL partner and other cross functional teams
• Support the manufacturing sites during Regulatory audits
• Should have the sound knowledge on GMP/QMS/Plant operations

Requirements

Master of Pharmacy