Manager – Regulatory Affairs (Mature Products Team)
Location: Bangalore, Karnataka, India (560064)
Company: Teva Pharmaceuticals
Job ID: 65165
Employment Type: Full-time
Posted On: December 24, 2025
About Teva Pharmaceuticals
Teva Pharmaceuticals is a global leader in generic and specialty medicines, committed to improving access to affordable healthcare worldwide. With operations in nearly 60 countries, Teva supports over 200 million patients daily and maintains one of the industry’s most extensive portfolios of essential medicines recognized by the World Health Organization. Teva offers a collaborative, inclusive, and performance-driven environment where regulatory professionals play a critical role in product lifecycle success.
Role Overview
Teva is seeking an experienced Manager – Regulatory Affairs (Mature Products Team) to lead regulatory lifecycle management activities for mature innovative products across global markets. This role is responsible for supervising and critically reviewing regulatory submissions, developing submission strategies, and ensuring compliance with global regulatory requirements. The Manager will act as the Regulatory Product Lead, driving lifecycle activities including variations, renewals, safety submissions, and health authority interactions across EU, US, and international markets.
Key Responsibilities
Act as Regulatory Product Manager for assigned mature innovative products
Lead and oversee global lifecycle management activities, including variations, renewals, PSURs, DSURs, RMPs, and responses to Health Authority queries
Develop and execute regulatory submission strategies aligned with regional and global regulatory requirements
Supervise preparation, review, and timely submission of high-quality regulatory dossiers
Maintain and manage Regulatory Submission Trackers for worldwide markets
Serve as the primary regulatory point of contact for global and regional stakeholders
Collaborate with cross-functional teams (CMC, Quality, Manufacturing, Safety) to ensure accurate and compliant submissions
Manage regulatory systems, databases, and trackers to ensure data accuracy and compliance
Provide regulatory guidance, risk assessment, and alternative solutions for complex regulatory issues
Contribute to submission and approval KPI metrics and continuous improvement initiatives
Support additional regulatory projects and strategic initiatives as assigned
Experience Required
Minimum 10 years of total pharmaceutical industry experience
At least 8 years of hands-on Regulatory Affairs experience
Proven experience managing global lifecycle management activities
Strong exposure to EU, US FDA, and worldwide regulatory procedures
Demonstrated experience handling mature products and post-approval regulatory activities
Educational Qualifications
PharmD or Master’s degree in a scientific discipline or equivalent education with relevant experience
Master’s degree in Regulatory Affairs or Quality Assurance is preferred
Skills & Competencies
Strong understanding of CMC regulatory requirements
In-depth knowledge of ICH guidelines and US/EU regulatory frameworks
Ability to independently evaluate complex regulatory documents and determine appropriate actions
Excellent written and verbal communication skills
Strong stakeholder management and cross-functional collaboration abilities
High level of organizational and multitasking skills with attention to detail
Demonstrated critical thinking, problem-solving, and decision-making capabilities
Ability to operate effectively in a global, matrix-driven regulatory environment
Why Join Teva
At Teva, regulatory leaders contribute directly to sustaining patient access to essential medicines worldwide. The organization offers opportunities to work on global portfolios, influence regulatory strategy, and grow within a purpose-driven and inclusive culture.
Equal Employment Opportunity
Teva Pharmaceuticals is committed to equal employment opportunity and fostering a diverse and inclusive workplace. Employment decisions are made without regard to age, race, religion, gender, disability, sexual orientation, gender identity, or any other legally protected status. Reasonable accommodations are available throughout the recruitment process.
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