Manager – Regulatory Affairs (Mature Products Team)
Company: Teva Pharmaceuticals
Location: Bangalore, Karnataka, India (560064)
Employment Type: Full-Time
Functional Area: Regulatory Affairs – Life Cycle Management
Industry: Pharmaceuticals / Generics & Innovative Medicines
Experience Required: 10+ Years (8+ Years in Regulatory Affairs)
Job ID: 65165
Posting Date: November 25, 2025
About Teva Pharmaceuticals
Teva Pharmaceuticals is a global leader in generic and specialty medicines, operating across nearly 60 countries with a diverse and inclusive workforce. Every day, over 200 million patients worldwide rely on Teva medicines, many of which are listed on the World Health Organization’s Essential Medicines List. Teva is driven by a mission to make quality healthcare more affordable and accessible, while continuously advancing regulatory excellence and patient safety.
Role Overview
The Manager – Regulatory Affairs (Mature Products Team) is responsible for the strategic oversight, preparation, and critical review of global regulatory submissions for mature innovative products. This role leads life cycle management (LCM) regulatory activities across multiple markets, ensuring compliance with regional and global regulatory requirements while meeting internal timelines.
The Manager acts as the regulatory product owner, providing expert regulatory guidance, managing complex regulatory issues, and collaborating with cross-functional and global teams to support submissions, variations, renewals, and Health Authority interactions.
Key Responsibilities
Lead and manage global Life Cycle Management (LCM) activities for assigned mature products
Supervise, review, and approve high-quality regulatory submissions in compliance with US FDA, EU, and other global regulatory requirements
Develop and execute regulatory submission strategies aligned with market-specific regulations
Plan and maintain the Regulatory Submission Tracker for worldwide markets
Manage regulatory deliverables including:
Variations and renewals
PSURs, DSURs, and RMPs
Responses to Health Authority (HA) questions and deficiency letters
Serve as the primary regulatory representative for assigned products, working closely with global and regional stakeholders
Oversee and maintain regulatory databases, systems, and trackers, ensuring data accuracy and compliance
Provide regulatory input to KPI metrics related to submissions and approvals
Evaluate complex regulatory issues and provide clear, actionable recommendations to senior leadership
Support additional regulatory projects and continuous improvement initiatives as assigned
Required Experience & Qualifications
PharmD or MS in a scientific discipline, or equivalent education with relevant regulatory experience
Master’s degree in Regulatory Affairs or Quality Assurance is preferred
Minimum 10 years of pharmaceutical industry experience, with:
At least 8 years in Regulatory Affairs
Demonstrated experience across EU, US, and other global markets
Proven experience managing life cycle management regulatory activities
Strong understanding of CMC requirements, including hands-on experience with US FDA and EU-CP submissions and procedures
In-depth knowledge of ICH guidelines and global regulatory frameworks
Ability to critically evaluate regulatory documents and determine appropriate regulatory actions
Excellent written and verbal communication skills with strong stakeholder engagement capability
Strong organizational, multitasking, and project management skills with high attention to detail
Demonstrated critical thinking, logical reasoning, and problem-solving abilities
Ability to work independently in a global, matrixed environment
Why Join Teva
Lead regulatory strategy for mature innovative products with global impact
Exposure to worldwide regulatory authorities and complex LCM activities
Collaborative, inclusive, and performance-driven work culture
Opportunity to influence regulatory decision-making at a global level
Long-term career growth within a globally recognized pharmaceutical organization
Internal Applicants
Current Teva employees are encouraged to apply via the Employee Central internal career portal. Internal applications receive priority consideration and provide access to roles exclusive to Teva employees.
Equal Employment Opportunity Statement
Teva Pharmaceuticals is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. Employment decisions are made without regard to age, race, religion, gender, disability, sexual orientation, gender identity, veteran status, national or ethnic origin, or any other legally protected status. Reasonable accommodations are available throughout the recruitment process upon request.
SEO Keywords for Search Visibility
Regulatory Affairs Manager Jobs, Life Cycle Management Regulatory Affairs, Mature Products Regulatory Affairs, Pharma Regulatory Jobs Bangalore, US FDA EU Regulatory Affairs, CMC Regulatory Manager, Global Regulatory Affairs Careers
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