Regulatory Affairs Intelligence Mgr

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