Job Title:
Manager – Regulatory Affairs, Labeling
Date Posted:
17 Sept 2025
Location:
Bangalore, India, 400706
Company:
Teva Pharmaceuticals
Job ID:
61891
Company Overview:
Teva Pharmaceuticals is a global leader in generic medicines and a producer of many products on the WHO Essential Medicines List. The company’s mission is to make healthcare more affordable and accessible worldwide. Teva operates in nearly 60 countries with a diverse workforce and continues to innovate to improve global health outcomes.
Role Overview:
The Manager – Regulatory Affairs, Labeling, will supervise, critically review, and approve US generic labeling documents (ANDA/505(b)(2)) prepared by US and India teams (Mumbai/Bangalore). The role ensures compliance with FDA regulations, internal processes, and company timelines. The Manager will act as a Subject Matter Expert (SME) in US labeling, including SPL, PADERs, and Annual Reports (AR), and provide guidance to team members while handling own assignments when required.
Key Responsibilities:
Supervise and assign projects to direct reports and external team members in the US and India.
Serve as SME for US labeling, including review, development, and electronic compilation of documents to align with FDA regulations and guidance.
Ensure labeling content meets legal and regulatory requirements, including carve-outs related to patents/exclusivities.
Maintain and update labeling trackers, monitor project timelines, and report metrics.
Communicate, plan, and prioritize work for the team; provide training and development for team members.
Collaborate with Regulatory Operations to ensure timely eCTD submissions.
Interface with cross-functional teams to align labeling with product/device strategy.
Develop, revise, and provide training on SOPs/Work Instructions as required.
Attend relevant meetings and maintain current knowledge of US regulations, guidelines, and SOPs.
Perform additional job-related duties as required by management.
Required Qualifications:
M.Pharm / B.Pharm with a scientific or regulatory background, or equivalent education/experience.
Minimum 8+ years of US labeling experience.
At least 1 year of supervisory experience preferred.
6–7 years of pharmaceutical industry experience specifically in Regulatory Affairs and US ANDA/505(b)(2) labeling.
Strong knowledge of FDA regulations, guidances, and US generic labeling requirements.
Experience in developing SPL content and managing labeling for ANDA/505(b)(2) submissions.
Skills & Competencies:
Strong leadership and team management skills.
Excellent communication and interpersonal skills.
Attention to detail, organization, and time management.
Ability to mentor and train team members effectively.
Knowledge of SOPs, WIs, and regulatory document management.
Equal Opportunity Statement:
Teva Pharmaceuticals is committed to a diverse and inclusive workplace. All employment decisions are based on business requirements, merit, and qualifications without regard to age, race, religion, sex, disability, sexual orientation, gender identity, or other legally protected status. Reasonable accommodations will be provided to support candidates during the recruitment process.
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