Who we areTogether, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityThe RA Associate III is responsible for preparing and/or reviewing high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2), as required. This role ensures compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives.The candidate must demonstrate the ability to work independently and possess a strong knowledge of US FDA labeling regulations and guidance documents, applying this knowledge effectively across all work output. Additionally, they will be responsible for creating compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information, and adhering to compliance requirements for importation, bulk listings, and related processes.How you'll spend your day
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