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Mgr Regulatory Affairs - Mature Products Team

Teva Pharmaceuticals
Teva Pharmaceuticals
8-10 years
preferred by company
10 Jan. 13, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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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