Regulatory Affairs Associate III

Roles & Responsibilities
• Prepare, review, and compile high-quality US Gx labeling documents for ANDA and 505(b)(2) submissions
• Act as Subject Matter Expert (SME) for FDA US Gx labeling regulations and related guidance
• Develop, QC, proofread, edit, and format labeling documents in alignment with Reference Listed Drug (RLD) and regulatory requirements
• Prepare and submit complete labeling responses to the FDA through appropriate eCTD filing modes
• Develop and maintain Structured Product Labeling (SPL) documents, including data elements and site establishment information
• Troubleshoot SPL validation errors within labeling software systems
• Manage labeling carve-outs related to patents and exclusivities
• Coordinate with Regulatory Operations to ensure timely submission of safety labeling changes, RLD updates, annual reportable changes, and eMedication Guide initiatives
• Collaborate with cross-functional teams including IP, Marketing, CMC, and Device teams to support product strategy
• Perform quality reviews of labeling and submission documents
• Support team operations by attending project meetings and acting as backup to the Team Lead
• Train and mentor junior team members and new labeling personnel
• Maintain up-to-date knowledge of US FDA regulations, guidelines, databases, and SOPs
• Perform additional regulatory tasks as assigned by management

Qualification
• M.Sc/ M.Pharm / B.Pharm with a scientific or regulatory background

Experience
• Total Experience: Minimum 6 years
• Relevant Experience: 6 years in Pharmaceutical Regulatory Affairs with strong focus on US Gx labeling

Skills
• In-depth knowledge of FDA US generic labeling regulations and guidances
• Hands-on experience with ANDA and 505(b)(2) labeling submissions
• Expertise in SPL authoring, validation, and troubleshooting
• Strong attention to detail with excellent QC and documentation skills
• Ability to work independently with minimal supervision
• Effective communication and cross-functional collaboration skills
• Familiarity with eCTD submission processes

About the Organization
Teva Pharmaceuticals is a global biopharmaceutical leader combining innovative medicines with a world-class generics portfolio. With a strong commitment to quality, collaboration, and patient care, Teva empowers employees to grow professionally while making a meaningful impact on global healthcare.