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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. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
THIS POSITION IS ELIGIBLE FOR THE EMPLOYEE REFERRAL PROGRAM
Actavis Laboratories FL, Inc. is seeking a Regulatory Affairs Associate III (Weston, FL) to 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 ANDAs 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 guidances distributed by FDA. Train on internal SOPs (Standard Operating Procedure) and requirements as applicable. Assist in providing regulatory strategy for assigned R&D projects.
Your experience and qualifications
Requires a Bachelor's Degree in Life Sciences, Chemistry or a related field, and 2 years of Regulatory experience. Must have experience with: Working on New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) and its amendments, supplements for oral dosage forms; Regulatory guidances related to US Food and Drug Administration (USFDA) and ICH; Electronic documents managements systems such as Trackwise, electronic common technical documents (eCTD) per FDA and ICH guidances; and MS word, MS Power Point, and MS Excel.
Apply at https://www.tevapharm.com/your-career/; reference Req. 55591.
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