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 chance to better health worldwide, together.

The Opportunity

The 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 assure 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 the Associate II.

How You’ll Spend Your Day
- Maintain 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

📌 Regulatory Affairs Associate II (India)
🏢 Teva Pharmaceutical
📍 India