Teva Regulatory Affairs Associate III 

United States, Florida, Weston 

644660030

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.

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.

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