Job Information
Teva Pharmaceuticals Regulatory Affairs Associate III in Weston, Florida
Regulatory Affairs Associate III
Date: May 21, 2024
Location:
Weston, United States, Florida, 33331
Company: Teva Pharmaceuticals
Job Id: 55591
Who we are
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.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran