Regulatory Affairs Associate II
Navi MumbaiFull-time4–7 yrsPosted 3 weeks ago
Mid-level pharma role at Teva in Navi Mumbai. Needs 4+ years and an M.Pharm.
About the role
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. 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.
What you'll do
- Be part of a high-performing, inclusive culture that values fresh thinking and collaboration
- Have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together
- Responsible for independently evaluating change controls (intended for post approval changes)
- Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports
What you need
- Regulatory affairs
- Documentation
- Communication