Regulatory Affairs Intelligence Mgr Amgen Technology Private Limited

3.0 - 5.0 years

2 - 6 Lacs

Hyderabad, Telangana, India

On-site

Key Responsibilities Intelligence Gathering & Analysis Monitor and analyze the global regulatory landscape for assigned therapeutic or regional areas Compile and synthesize new or updated regulatory requirements from local affiliates Prepare deliverables such as monitoring reports, bulletins, and landscape summaries Ensure outputs are clear, actionable, and aligned with business needs Provide insights or recommendations to inform filing strategies and compliance planning Tools & Data Management Manage and maintain regulatory intelligence tools, databases, and repositories Ensure systems are up-to-date and easily accessible by stakeholders Build or configure new dashboards, tracking tools, or databases as needed Serve as a technical point of contact for tool improvements and support Cross-Functional Support Work with Regulatory Policy, Product Regulatory Leads, and other stakeholders Supply timely data or regulatory insights for product strategy discussions Support cross-functional initiatives by providing relevant regulatory intelligence Respond to intelligence-related requests from internal teams promptly and accurately Progress Tracking & Process Improvement Track progress against intelligence gathering plans and timelines Report regularly to the RI Director on task status and potential bottlenecks Identify and propose process enhancements to increase efficiency or accuracy Participate in functional improvement initiatives across tools, workflows, and communication Knowledge & Skills Regulatory Knowledge Solid understanding of regulatory affairs principles, global submission processes, and regional regulatory requirements Ability to interpret health authority guidance and summarize critical impacts Awareness of how regulatory changes affect product lifecycle and submissions Attention to Detail and Analytical Skills Strong data analysis and synthesis abilities Accuracy in interpreting and entering regulatory data Ability to identify key changes, trends, and propose relevant insights Technical and Project Skills Proficiency with regulatory intelligence databases and information systems Ability to configure or optimize internal tools such as SharePoint, dashboards, or custom trackers Good project coordination skills with the ability to manage multiple workstreams Strong communication skills, both written and verbal, for effective reporting and collaboration Qualifications Education & Experience Bachelor's degree in life sciences, regulatory affairs, or a related field (Master's preferred) 35 years of experience in regulatory affairs, regulatory operations, or related drug development roles Preferred Background Experience in regulatory intelligence or regulatory policy tracking Familiarity with tools such as Tarius or other regulatory subscription databases Previous work in pharmaceutical or biotech industry with a global regulatory focus Demonstrated ability to understand and communicate regulatory impacts clearly

Posted 1 week ago

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