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 The opportunity The Associate III with minimal to no guidance prepares reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines The Associate III will be responsible for independently evaluating change controls intended for post approval changes will assure the CC is complete and accurate and in the absence of any comments will progress the CC accordingly In addition he she will monitor any all Regulatory or team databases and trackers and will proactively and accurately update them when changes are required Annual Reports supplements post approval submissions and assisting management with the training of regulatory staff will be the primary responsibilities of the Associate III How you ll spend your day Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports Independently and proactively request documentation required for annual reports compile finalize and publish for managements review and subsequent dispatch to the Agency Independently work on supplements compile and publish for managements review Take a proactive approach for more complex submissions and contact internal stakeholders when needed to gain further insight on any given supplement Convey findings to management and incorporate any all applicable information in the submission to ensure a quality and a right first time submission Assist management and proactively train Associate I s and Associate II s on guidance s internal processes procedures databases and trackers Other projects and duties as required assigned Process improvement Your experience and qualifications M Pharma degree in RA QA discipline a plus Minimum 5 years pharmaceutical industry experience Regulatory Analytical QA laboratory or production experience preferred Demonstrates an understanding of ICH and FDA guidelines Demonstrates the ability to evaluate regulatory documents and determine appropriate action Demonstrates excellent verbal and written communication skills Demonstrates excellent organization skills and the ability to multi-task detail oriented Possesses strong critical and logical thinking 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 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 chance 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