Regulatory Affairs Associate II

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

• 4–7 yrs of experience
• Regulatory affairs
• Documentation
• Communication
• M.Pharm