Regulatory Affairs Associate III – US Generics Labeling
Location: Bangalore, Karnataka, India, 560064
Company: Teva Pharmaceuticals
Date Posted: February 5, 2026
Job ID: 66283
Employment Type: Full-Time
Industry: Pharmaceuticals | Regulatory Affairs | US Generics
About Teva Pharmaceuticals
Teva is a global biopharmaceutical leader, combining innovation in neuroscience and immunology with a world-class generics business. Committed to improving patient access to high-quality medicines, Teva fosters an inclusive, collaborative, and growth-oriented environment where professionals can thrive, innovate, and advance their careers.
Learn more: www.tevapharm.com
Job Summary
Teva is seeking a highly experienced Regulatory Affairs Associate III to manage US Generics (Gx) labeling activities for ANDA and 505(b)(2) submissions. The ideal candidate will ensure compliance with FDA labeling regulations and guidances, independently prepare and review labeling documents, and coordinate cross-functional teams to deliver high-quality, on-time submissions.
This role requires subject matter expertise in Structured Product Labeling (SPL), FDA submissions, and regulatory documentation, along with strong analytical, technical, and collaborative skills.
Key Responsibilities
Serve as Subject Matter Expert (SME) for US Gx labeling, including preparation, QC, proofing, editing, formatting, and electronic compilation of labeling documents.
Develop labeling content aligned with Reference Listed Drug (RLD) and company objectives while maintaining compliance with FDA regulations.
Create, review, and manage Structured Product Labeling (SPL) documents, including content, data elements, site establishments, and validation troubleshooting.
Handle complex labeling updates such as carve-outs due to patent/exclusivity protections.
Collaborate with US Regulatory Labeling Team, Regulatory Operations, IP, Marketing, CMC, and Device teams to align labeling with product strategy.
Perform quality review of labeling and submission documents, ensuring completeness, accuracy, and regulatory compliance.
Provide training and mentorship to junior team members and new labeling personnel.
Maintain up-to-date knowledge of US FDA regulations, guidances, databases, and company SOPs applicable to Gx labeling.
Support projects including RLD updates, safety labeling changes, Annual Reportable Changes, electronic Medication Guide initiatives, and other assigned projects.
Serve as backup to Team Lead as needed.
Required Qualifications & Experience
Educational Qualification:
M.Sc., M.Pharm, or B.Pharm in a Scientific or Regulatory discipline, or equivalent combination of education and experience
Experience:
6 years of relevant experience in Regulatory Affairs with a focus on US Generics labeling within the pharmaceutical industry
Proven expertise in FDA labeling regulations, ANDA/505(b)(2) submissions, and SPL development
Skills & Competencies:
Strong analytical, organizational, and project management skills
Ability to work independently and meet tight regulatory deadlines
Excellent communication, collaboration, and mentoring skills
Proficient in regulatory databases, eCTD submissions, and labeling software
Attention to detail and high compliance and quality standards
Reporting
Reports to: Senior Manager – Regulatory Affairs
Why Teva?
Be part of a global, high-performing, inclusive organization
Work on critical US Gx regulatory submissions impacting patient access worldwide
Access opportunities for career growth, skill development, and cross-functional collaboration
Benefit from flexible working schedules, health support programs, and community engagement initiatives
Teva is committed to equal employment opportunity and workplace accessibility. All applicants will be considered regardless of age, race, religion, gender, disability, or other protected status. Accommodations are available for candidates requiring support during the recruitment process.
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