Regulatory Affairs Associate II (Pharmacy)

Roles & Responsibilities
• Prepare, review, and submit high-quality regulatory submissions to the US FDA within defined timelines
• Maintain approved ANDA applications and manage Annual Reports in compliance with FDA regulations
• Independently evaluate post-approval change controls (CCs) and ensure accuracy and completeness
• Compile, publish, and submit annual reports and supplements for management review
• Assist on complex supplements and independently handle simple supplements
• Maintain regulatory databases, trackers, and documentation in real time
• Stay updated with FDA post-approval guidance and regulatory requirements
• Train and mentor Regulatory Affairs Associate I on internal processes and systems
• Support additional regulatory projects as assigned

Qualifications
• Master of Pharmacy (M.Pharm)- Regulatory Affairs / Quality Assurance preferred
• Bachelor’s degree in Pharmacy or related discipline

Experience
• Minimum 4+ years of experience in the pharmaceutical industry
• Experience in Regulatory Affairs preferred; QA, Analytical, Production, or Lab exposure is an advantage

Skills
• Strong knowledge of FDA post-approval regulations and ANDA lifecycle management
• Good understanding of regulatory documentation and submission processes
• Proficiency in MS Word, Excel, and regulatory databases
• Excellent written and verbal communication skills
• Strong attention to detail, organization, and multitasking ability
• Ability to work independently and collaboratively in cross-functional teams

About the Company
Teva Pharmaceuticals is a global leader in generic and specialty medicines, operating across nearly 60 countries. With a mission to make healthcare more affordable and accessible, Teva supports the health of over 200 million patients worldwide every day through high-quality, essential medicines and a strong commitment to innovation, diversity, and inclusion.