Regulatory Affairs Associate III

4 days ago

India Teva Full time

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 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?

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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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