Associate II, Complex Gx, Regulatory Affairs

Roles & Responsibilities
• Prepare, review, and submit high-quality regulatory filings (pre- and post-approval) for US FDA–regulated complex generic products including inhalation, ophthalmic, implant, and drug–device combinations
• Manage original applications, amendments, deficiency responses (IRs, DRLs, CRLs), and post-approval supplements
• Evaluate change controls and determine appropriate regulatory pathways (PAS, CBE-30, CBE-0, AR) in coordination with regulatory management
• Compile and submit post-approval changes in compliance with FDA, ICH guidelines, and internal SOPs
• Support early FDA engagement to align development strategies and reduce regulatory risks
• Act as a regulatory point of contact for cross-functional teams (R&D, QA, Manufacturing, Packaging, DMF holders) as needed
• Monitor regulatory timelines, identify documentation gaps, and ensure “Right-First-Time” submissions
• Track regulatory intelligence and monitor FDA databases such as Drugs@FDA and Orange Book
• Participate in audits, inspections, and continuous process improvement initiatives

Qualifications
• Master’s degree in Pharmacy with specialization in Regulatory Affairs / Quality Assurance preferred

Experience
• Minimum 4+ years of pharmaceutical industry experience
• Hands-on experience with complex generics such as inhalation, ophthalmic, implant, or drug–device combination products preferred

Skills
• Strong knowledge of US FDA and ICH regulatory guidelines
• Experience in regulatory submissions and post-approval change management
• Excellent written and verbal communication skills
• Strong organizational skills with attention to detail and multitasking ability
• Analytical, critical, and logical thinking skills
• Ability to work independently and collaboratively across cross-functional teams

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