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
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.
Manage end-to-end LCM activities:
Variations
Renewals
PSURs / DSURs
RMPs
Health Authority (HA) query responses
Act as product owner for assigned portfolio.
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.
Coordinate with cross-functional teams (CMC, QA, manufacturing).
Track submission timelines using regulatory trackers.
Ensure timely submissions and approvals.
Manage regulatory databases, trackers, and documentation systems.
Ensure accurate updates and compliance with internal systems.
Evaluate complex regulatory issues.
Provide strategic recommendations and alternatives.
Handle escalations and regulatory risks.
Contribute to KPI tracking for submissions and approvals.
Monitor efficiency and compliance metrics.
Strong experience in post-approval lifecycle management.
Knowledge of CMC requirements and global regulatory submissions.
Ability to own products + decisions, not just execute tasks.
Strong regulatory strategy development capability.
Ability to evaluate complex regulatory scenarios.
Strong logical and critical thinking skills.
Strong stakeholder management across global teams.
Excellent written and verbal communication.
Strong organization and multitasking ability.
High attention to detail and deadline management.
Experience with US FDA and EU regulatory procedures.
RA/QA specialization or master’s degree.
Experience in managing global regulatory portfolios.
Lifecycle management (LCM) ownership
Regulatory strategy & submissions
Product ownership mindset
Cross-functional leadership
Risk assessment & decision-making
Regulatory compliance & documentation
Teva Pharmaceuticals is a global leader in generic and specialty medicines, serving millions worldwide with a strong focus on affordability, innovation, and regulatory excellence.
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