Sr Executive / Executive - Regulatory Affairs (API)

JOB DESCRIPTION:

Preparation of DMF/ASMF in compliance with regulatory standards, country specific guidelines and procedures.

• Experience in handling API drug submissions to regulated markets Canada, UK, Europe, Brazil, China, Japan, US etc.
• Filing amendments, updates with relevant health agencies
• Knowledge and experience in handling submission of documentation to regulatory agency via e-CTD software
• Preparation of response to queries received from health authorities and customers
• Evaluation of regulatory impact and review of QMS documentation
• Coordination with various stake holders at site for documentation
• J articipation in project review meeting regarding new products and providing regulatory feedbackJ