Job Title: Manager – Regulatory Affairs, Labeling
Job ID: 61891
Location: Bangalore, India – 400706
Date Posted: August 19, 2025
Company: Teva Pharmaceuticals
Employment Type: Full-time
About Teva Pharmaceuticals
At Teva, we are united by a mission to make good health more affordable and accessible—impacting over 200 million people globally every day. As a leading manufacturer of generic medicines and a key contributor to the World Health Organization’s Essential Medicines List, Teva brings together people from nearly 60 countries with diverse backgrounds, working together to make a difference in the lives of patients worldwide.
Position Summary
The Manager – Regulatory Affairs, Labeling will lead the development, review, and submission of U.S. Generic (Gx) labeling documents for products filed under ANDA and 505(b)(2) applications. The role involves supervising a cross-regional team (U.S. and India), managing documentation and regulatory compliance per FDA requirements, and maintaining internal tracking systems and databases. This is a hands-on leadership role, requiring both managerial oversight and active contribution to projects.
Key Responsibilities
Lead daily operations of the labeling team while also managing individual projects as needed.
Act as Subject Matter Expert (SME) for all U.S. labeling-related tasks, including SPL (Structured Product Labeling), PADERs, and Annual Reports.
Supervise and provide direction to team members in the U.S. and India (Mumbai/Bangalore).
Ensure labeling projects are assigned, tracked, and delivered according to FDA timelines and company goals.
Develop and review labeling content for ANDA/505(b)(2) submissions, ensuring alignment with the Reference Listed Drug (RLD) and FDA safety requirements.
Maintain and update labeling trackers and databases for internal visibility and compliance reporting.
Collaborate closely with:
Regulatory Operations to ensure timely and compliant eCTD submissions.
Cross-functional teams (e.g., Product, Device, Strategy) to align on product development plans and lifecycle management.
Train, develop, and mentor team members, including creating/revising SOPs and Work Instructions (WIs).
Ensure adherence to all U.S. FDA labeling regulations, internal SOPs, and relevant guidances.
Contribute to or lead labeling carve-out strategies related to patent or exclusivity-protected language.
Represent Regulatory Affairs in relevant meetings.
Maintain a metrics dashboard to monitor team performance and project progress.
Stay current on industry regulations and FDA updates affecting U.S. labeling requirements.
Qualifications & Experience
Educational Requirements
Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm) or related scientific/regulatory discipline.
Equivalent combination of education and relevant experience may also be considered.
Experience Requirements
Minimum 8+ years of U.S. labeling experience in the pharmaceutical industry.
At least 1 year of supervisory or team leadership experience (preferred).
Proven experience with:
ANDA and 505(b)(2) regulatory pathways.
Labeling content development, SPL generation, and submission processes.
U.S. regulatory standards and FDA guidelines.
Skills & Knowledge
Strong expertise in FDA regulations and labeling guidances.
Proficient in managing Structured Product Labeling (SPL) content and XML data.
Experience with eCTD submissions and regulatory document compilation.
Working knowledge of PADERs, annual reports, and labeling carve-outs.
Strong organizational and project management skills.
Effective communication, cross-functional collaboration, and team development.
Proficiency in documentation systems and internal tracking tools.
Equal Employment Opportunity
Teva Pharmaceuticals is committed to equal opportunity in employment and a diverse and inclusive workplace. We do not discriminate based on:
Age, race, creed, color, religion, sex, disability, pregnancy, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin, or any other legally protected status.
If you require accommodation during the recruitment process, please inform us in advance. All requests will be treated confidentially and used solely to ensure a fair and accessible selection process.
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