Regulatory Affairs Associate III

Responsibilities

• Prepare, review, and submit high-quality regulatory submissions to the FDA within company timelines.
• Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.
• Independently evaluate post-approval change controls to ensure accuracy and completeness.
• Compile and publish supplements, proactively contacting internal stakeholders to ensure quality submissions.
• Monitor and update regulatory databases and trackers accurately.
• Assist management by training Associate I and Associate II staff on internal processes, procedures, and guidance.
• Support process improvement initiatives and other assigned projects.

Requirements

• Minimum of 5+ years of experience in the pharmaceutical industry (Regulatory, Analytical, QA, laboratory, or production experience preferred).
• Strong understanding of ICH and FDA guidelines.
• Proven ability to evaluate regulatory documents and determine appropriate actions.
• Excellent verbal and written communication skills.
• Strong critical and logical thinking skills.
• Exceptional organization and multi-tasking abilities with high attention to detail.

Preferred Qualifications

• M. Pharma degree in a Regulatory Affairs (RA) or Quality Assurance (QA) discipline.

Benefits

• Comprehensive medical insurance, OPD coverage, and annual health checkups.
• Term life and accident insurance.
• Confidential emotional wellbeing support through the Optum Employee Assistance Program.
• Opportunities for professional growth through the R&D Academy, mentorship, and global project collaboration.
• Healthy meals at work and various holistic wellbeing initiatives.

About the Company

Teva is a leading innovative biopharmaceutical company dedicated to addressing patients' needs through neuroscience, immunology, and high-quality generic medicines worldwide. We foster a high-performing, inclusive culture that values fresh thinking, collaboration, and the opportunity to better health globally.