Regulatory Affairs Associate III – Mature Product Team
Company: Teva Pharmaceuticals
Location: Bangalore
Job Type: Full-Time
Experience: Typically 6–8+ Years (Regulatory Affairs – Post Approval)
Qualification: B.Pharm / M.Pharm / Science Graduate or Postgraduate
Salary Range: Not Specified
Teva Pharmaceuticals is hiring a Regulatory Affairs Associate III for its Mature Product Team, responsible for independently managing post-approval regulatory activities across global markets.
This role focuses on lifecycle management (LCM) of approved products, including CMC change control, regulatory strategy, and compliance across regions like US, EU, and ROW markets.
Lead CMC change impact assessments and change control activities.
Classify regulatory changes (minor, moderate, major) and define submission strategy.
Manage lifecycle activities for multiple dosage forms across global markets.
Develop regulatory strategies for US, EU, APAC, LATAM, and ROW markets.
Ensure compliance with global regulatory guidelines.
Adapt strategies based on evolving regulatory requirements.
Independently execute regulatory submissions and post-approval updates.
Ensure timelines and compliance requirements are met.
Support global product maintenance and variations.
Collaborate with internal teams (CMC, QA, manufacturing, etc.).
Communicate effectively with regional and global stakeholders.
Maintain strong cross-functional relationships.
Perform risk-benefit analysis for regulatory changes.
Identify potential regulatory risks and propose mitigation strategies.
Manage multiple projects simultaneously.
Ensure timely delivery under tight deadlines.
Maintain attention to detail while keeping strategic alignment.
Strong understanding of ICH guidelines and global regulatory frameworks.
Experience in post-approval regulatory activities (CMC focus).
Ability to connect big picture + detailed execution.
Strong risk assessment and decision-making skills.
Excellent written and verbal communication.
Strong stakeholder management skills.
Ability to multitask and meet deadlines.
High attention to detail and organizational skills.
Experience with multiple dosage forms and global submissions.
Exposure to US FDA, EU EMA, and ROW regulatory environments.
Strong experience in lifecycle management of generic products.
Post-approval regulatory strategy
CMC change control & lifecycle management
Global regulatory compliance
Stakeholder collaboration
Risk assessment & decision-making
Project and timeline management
Teva Pharmaceuticals is one of the world’s largest generic medicine manufacturers, providing affordable healthcare solutions globally and serving millions of patients every day.
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