Regulatory Affairs Associate III

We Are Teva

Our Team, Your Impact

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 Skills and Experience

• 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.

How We'll Take Care of You

At Teva India, care is at the heart of how we work. From your first day,you'llbe welcomed intoa people-first culture built on inclusion, respect, and belonging.

That supportextends to you and your loved ones through benefits designed for real life. These includecomprehensive medical insurance, OPD coverage, annual health checkups, term life and accident insurance, and confidential emotional wellbeing support through our Optum Employee Assistance Program.You'llalso enjoy healthy meals at work,holisticwellbeing initiatives, andvolunteering programs that help you give back to the community.

Your growthmatterstoo.You'llhaveopportunitiestobuild future-ready skills, collaborateon projectswith global teams, explore internal career opportunities, and learn through programs such asour AI-enabledTevaTwistprogram, R&D Academy,continuingeducation,andmentorship.

Join ourvibrant workplace,wherewecelebrate milestones, festivals, achievements, and community impact together.

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Teva's Equal Employment Opportunity Commitment