We Are Teva

We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

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.

Already Working @TEVA

Make sure to apply through our internal career site on Twist-your one-stop shop for career development

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.

Regulatory Affairs Associate III