Regulatory Affairs Associate II
2 days ago
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 opportunityThe Associate II, with moderate to minimal guidance, prepares, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines.The Associate II will be responsible for independently evaluating change controls (intended for post approval changes), will ensure the CC is complete and accurate and will consult his/her manager/designee prior to progressing the CC.In addition, he/she will accurately populate and maintain any/all Regulatory or team databases and trackers in real time, as directed by their manager or Designee. Annual reports, supplements and post approval submissions will be the primary responsibilities of Associate II. How you'll spend your dayMaintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports. Under minimal supervision, proactively request documentation required for annual reports, compile and publish for managements review.Under management's direction/assignment, work independently on simple supplements, compile and publish for managements review. Assist management on more complex supplement to gain experience. Further educate oneself on FDA Regulations by reviewing any/all applicable post approval guidance's to understand and accurately assess change controls. When needed, train Associate I's on internal processes, procedures, databases and trackers.Other projects and duties as required/assigned Your experience and qualificationsM. Pharma degree in RA/QA discipline, a plus.Minimum four years plus pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory or production experience preferred.Basic computer skills such as Word, Excel and familiarity with the internetAbility to work independently and on teamsGood verbal and written communication skillsMust be well organized, detail oriented, have the ability to multi-task and manage changing priorities 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.
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