Regulatory Affairs Associate III – US Generic Labeling
Job ID: 66283
Company: Teva Pharmaceuticals
Location: Bangalore, India (560064)
Employment Type: Full-Time
Function: Regulatory Affairs | US Generic Labeling | ANDA | 505(b)(2)
Reports To: Senior Manager, Regulatory Affairs
Posting Date: February 5, 2026
About the Company
Teva Pharmaceuticals is a global leader in innovative biopharmaceuticals and high-quality generic medicines. With a strong presence across regulated markets, Teva is committed to improving patient health through innovation, access, and scientific excellence. The organization fosters an inclusive, performance-driven culture that values collaboration, continuous learning, and professional growth.
Role Overview
The Regulatory Affairs Associate III plays a critical role in the preparation, review, and submission of US generic drug labeling for products filed under ANDA and 505(b)(2) pathways. This position requires strong independent working capability, in-depth expertise in FDA US Gx labeling regulations, and hands-on experience with Structured Product Labeling (SPL) and eCTD submissions.
The role supports timely, compliant labeling submissions while ensuring alignment with Reference Listed Drugs (RLDs), FDA guidance, and internal quality standards.
Key Responsibilities
Serve as a Subject Matter Expert (SME) for the development, review, and electronic compilation of US generic labeling documents for assigned ANDA and 505(b)(2) applications.
Prepare, QC, proofread, edit, and format labeling documents to ensure compliance with FDA regulations, guidance, and legal requirements.
Develop full labeling responses to FDA, including submission-ready documents using appropriate eCTD filing modes.
Author and review labeling content requiring carve-outs related to patent protections and exclusivity constraints.
Develop and maintain Structured Product Labeling (SPL) content and data elements in alignment with FDA regulations, including troubleshooting SPL validation errors.
Collaborate with US Regulatory Labeling, Regulatory Operations, and cross-functional stakeholders to support RLD updates, safety labeling changes, annual reportable changes, and electronic Medication Guide initiatives.
Coordinate with internal teams including Intellectual Property, Marketing, CMC, and Device teams to ensure regulatory alignment with product and device strategies.
Perform quality reviews of labeling and regulatory submission documents as assigned.
Participate in project and cross-functional team meetings to support labeling and regulatory strategies.
Act as a backup to the Team Lead and provide operational continuity when required.
Support onboarding and training of junior regulatory associates and new labeling personnel.
Assist in assignment and tracking of Reference Listed Drug labeling updates.
Maintain up-to-date knowledge of US FDA regulations, labeling guidance, internal SOPs, and regulatory databases.
Perform additional regulatory activities as assigned by management.
Required Qualifications
Education:
MSc, MPharm, BPharm, or equivalent degree in Pharmaceutical Sciences, Life Sciences, or Regulatory Affairs.
Experience:
Total Experience: Minimum 6 years in the pharmaceutical industry.
Relevant Experience: At least 6 years in Regulatory Affairs, with a strong focus on US Generic (Gx) Labeling, ANDA, and 505(b)(2) submissions.
Technical Expertise:
In-depth knowledge of FDA US labeling regulations and guidance.
Hands-on experience with SPL authoring, eCTD submissions, and FDA labeling databases.
Strong understanding of patent/exclusivity carve-outs and post-approval labeling changes.
Skills:
Excellent attention to detail and quality orientation.
Strong written and verbal communication skills.
Ability to work independently with minimal supervision in a collaborative team environment.
Work Environment & Benefits
Teva offers a supportive and flexible work environment designed to promote employee wellbeing and professional development. Benefits may include competitive leave policies, flexible work arrangements (role-dependent), health and wellness programs, and access to Teva’s global learning and career development platform.
Equal Employment Opportunity
Teva Pharmaceuticals is an equal opportunity employer and is committed to building a diverse and inclusive workforce. Employment decisions are made without regard to race, gender, age, disability, sexual orientation, gender identity, veteran status, or any other protected status under applicable laws. Reasonable accommodations are available throughout the recruitment process upon request.
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