Regulatory Affairs Associate III

Together, 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. Actavis Laboratories FL, Inc. seeks a Regulatory Affairs Associate III responsible for the following: Review change controls for approved Abbreviated New Drug Applications (ANDAs), unapproved but submitted ANDAs, and make appropriate regulatory determination. Write, review and compile documentation and data necessary for submission of assigned PINDs, INDs, ANDAs and NDAs with limited supervision from manager. Write, review and compile documentation necessary for responses to FDA Deficiency letters. Write, review and compile documentation and data for Correspondences and post approval supplements. Review applicable revised and new regulations and guidance’s distributed by FDA. Train on internal SOPs (Standard Operating Procedure) and requirements as applicable. Assist in providing regulatory strategy for assigned R&D projects. REQUIREMENTS:

Bachelor’s degree (or foreign equivalent) in Life Sciences, Chemistry, or a related field. Plus a minimum of 2 years of regulatory affairs experience, including: Solid oral dosage forms: tablets, hard gel capsules, softgel capsules, powders, granules, and pellets. Formulations: immediate-release, extended-release, delayed-release, complex generics (including peptides), and combination drug products. Regulatory submissions: P-INDs, INDs, NDAs, ANDAs. Responding to FDA deficiency comments and preparing submission responses. Regulatory advising for product launch readiness and post-approval changes. Familiarity with USFDA and ICH regulatory guidance. Experience with systems: Harmony Trackwise, VEEVA Vault (eCTD), Planisware, MS Word, PowerPoint, Excel. We offer a competitive benefits package, including comprehensive health insurance, retirement savings, time off, life and disability protection, and more. Actavis Laboratories FL, Inc. is an Equal Opportunity Employer (EEO/AA).

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