Job Title: Manager – Regulatory Affairs, Labeling
Date: August 19, 2025
Location: Bangalore, India, 400706
Company: Teva Pharmaceuticals
Job ID: 61891
About Us
Teva Pharmaceuticals is the world’s leading manufacturer of generic medicines and the proud producer of many products on the World Health Organization’s Essential Medicines List. Every day, over 200 million people worldwide take one of our medicines. With operations in nearly 60 countries and a highly diverse workforce, we strive to make healthcare more affordable and accessible while continuously looking for new ways to make a positive impact.
The Opportunity
The Manager, Regulatory Affairs – Labeling will:
Supervise, critically review, and approve US Gx labeling documents filed under ANDA/505(b)(2).
Ensure compliance with FDA regulations, internal processes, and company-driven timelines.
Oversee team databases and trackers, updating them as required.
Serve as a Subject Matter Expert (SME) in US labeling, including SPL, PADERs, and Annual Report compilation.
Provide direction, training, and support to US and India-based team members.
Ensure all FDA reporting obligations are met in line with business objectives and regulatory compliance.
Key Responsibilities
Leadership & Supervision
Act as a hands-on leader, managing both independent assignments and team deliverables.
Assign projects to US and Mumbai team members, ensuring timely execution.
Train, develop, and mentor direct reports in the US and India.
Create, revise, and train on SOPs/WIs as required.
Regulatory & Compliance
SME in preparation, review, and compilation of labeling documents in alignment with:
Reference Listed Drugs (RLDs)
FDA-solicited safety changes
Submission requirements for ANDAs/505(b)(2)s
Ensure development/review of Structured Product Labeling (SPL) documents (content + data elements).
Collaborate with Regulatory Operations to meet eCTD requirements for labeling submissions.
Monitor projects through the labeling tracker and maintain metrics for reporting.
Stay current with FDA labeling regulations, guidance documents, and internal SOPs/WIs.
Cross-Functional Collaboration
Work with external departments to align labeling strategy with product/device plans.
Participate in meetings relevant to labeling and regulatory responsibilities.
Develop labeling content requiring carve-outs for patent/exclusivity protections.
Other Duties
Attend to additional projects and responsibilities as assigned by management.
Qualifications & Experience
Education:
M.Pharm / B.Pharm with a scientific or regulatory background, or equivalent combination of education and experience.
Experience:
Total: Minimum 8+ years of US labeling experience (pharmaceutical industry).
Supervisory: At least 1 year of team leadership or supervisory experience preferred.
Relevant: 6–7 years of industry experience in Regulatory Affairs and US ANDA/505(b)(2) labeling.
Skills & Competencies:
In-depth knowledge of FDA labeling regulations and guidances.
SME in US labeling processes (SPL, PADERs, Annual Reports).
Strong organizational, communication, and leadership skills.
Ability to train and guide teams effectively across multiple geographies.
Why Join Us
Lead impactful projects in US labeling with global exposure.
Be part of a collaborative, diverse, and inclusive team.
Contribute to medicines that improve lives for millions worldwide.
Equal Employment Opportunity
Teva Pharmaceuticals is committed to equal opportunity in employment regardless of age, race, religion, gender, disability, sexual orientation, gender identity, veteran status, national origin, or any legally protected status. Accommodations will be provided during the recruitment process to ensure accessibility for all candidates.
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