Job Description

Responsibilities include, but are not limited to:

? Regulatory support for assigned projects through product development and lifecycle management of products for US market.

? Prepare technical documents required for submission of dossier as per country specific requirements.

? Prepare, develop, and maintain internal Regulatory informational trackers.

? Review and approve labels inline with US regulatory requirements for assigned products.

? Respond to consumer inquiries based on approved labels and product information.

? Coordinate the receipt of raw material regulatory documents from vendors.

? Preparation of module 1 sections including labelling sections for ANDA products.

? Perform drug listing of assigned products for US market.

? Support publishing of ANDA submissions including SPL Creation.

? Support manufacturing site for commercialization and life cycle management of the approved products.

? Other projects and duties as assigned by Senior Management

Job Type: Full-time

Pay: ₹15,000.00 - ₹25,000.00 per month

Work Location: In person