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Mgr Regulatory Affairs - Mature Products Team

Teva Pharmaceuticals
Teva Pharmaceuticals
8-10+ years
Not Disclosed
Bangalore, India
10 March 19, 2026
Job Description
Job Type: Full Time Education: PharmD / M.Pharm / MS 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

Company: Teva Pharmaceuticals
Location: Bangalore
Job Type: Full-Time
Experience: Typically 8–10+ Years (Regulatory Affairs)
Qualification: PharmD / M.Pharm / MS (RA/QA preferred)
Salary Range: Not Specified


Job Overview

Teva Pharmaceuticals is hiring a Manager – Regulatory Affairs (Mature Products Team) responsible for leading lifecycle management and regulatory submissions for approved products across global markets.

This role is a mid-senior leadership position where you don’t just execute—you own products, strategy, and submission outcomes.


Key Responsibilities

1. Lifecycle Management (Core Role)

  • Manage end-to-end LCM activities:

    • Variations

    • Renewals

    • PSURs / DSURs

    • RMPs

    • Health Authority (HA) query responses

  • Act as product owner for assigned portfolio.

2. Regulatory Strategy & Submissions

  • Develop submission strategies for global markets (US, EU, ROW).

  • Prepare and review regulatory dossiers for submission.

  • Ensure compliance with U.S. Food and Drug Administration, EU, and ICH guidelines.

3. Project & Stakeholder Management

  • Coordinate with cross-functional teams (CMC, QA, manufacturing).

  • Track submission timelines using regulatory trackers.

  • Ensure timely submissions and approvals.

4. Regulatory Operations

  • Manage regulatory databases, trackers, and documentation systems.

  • Ensure accurate updates and compliance with internal systems.

5. Decision Making & Problem Solving

  • Evaluate complex regulatory issues.

  • Provide strategic recommendations and alternatives.

  • Handle escalations and regulatory risks.

6. Performance & Metrics

  • Contribute to KPI tracking for submissions and approvals.

  • Monitor efficiency and compliance metrics.


Required Skills

Regulatory Expertise

  • Strong experience in post-approval lifecycle management.

  • Knowledge of CMC requirements and global regulatory submissions.

Strategy & Ownership

  • Ability to own products + decisions, not just execute tasks.

  • Strong regulatory strategy development capability.

Analytical Thinking

  • Ability to evaluate complex regulatory scenarios.

  • Strong logical and critical thinking skills.

Communication & Collaboration

  • Strong stakeholder management across global teams.

  • Excellent written and verbal communication.

Operational Excellence

  • Strong organization and multitasking ability.

  • High attention to detail and deadline management.


Preferred Qualifications

  • Experience with US FDA and EU regulatory procedures.

  • RA/QA specialization or master’s degree.

  • Experience in managing global regulatory portfolios.


Key Competencies

  • Lifecycle management (LCM) ownership

  • Regulatory strategy & submissions

  • Product ownership mindset

  • Cross-functional leadership

  • Risk assessment & decision-making

  • Regulatory compliance & documentation


About the Company

Teva Pharmaceuticals is a global leader in generic and specialty medicines, serving millions worldwide with a strong focus on affordability, innovation, and regulatory excellence.