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 repositoriesEnsure systems are up-to-date and easily accessible by stakeholdersBuild or configure new dashboards, tracking tools, or databases as neededServe as a technical point of contact for tool improvements and supportCross-Functional Support
Work with Regulatory Policy, Product Regulatory Leads, and other stakeholdersSupply timely data or regulatory insights for product strategy discussionsSupport cross-functional initiatives by providing relevant regulatory intelligenceRespond to intelligence-related requests from internal teams promptly and accuratelyProgress Tracking & Process Improvement
Track progress against intelligence gathering plans and timelinesReport regularly to the RI Director on task status and potential bottlenecksIdentify and propose process enhancements to increase efficiency or accuracyParticipate in functional improvement initiatives across tools, workflows, and communicationKnowledge & Skills
Regulatory Knowledge
Solid understanding of regulatory affairs principles, global submission processes, and regional regulatory requirementsAbility to interpret health authority guidance and summarize critical impactsAwareness of how regulatory changes affect product lifecycle and submissionsAttention to Detail and Analytical Skills
Strong data analysis and synthesis abilitiesAccuracy in interpreting and entering regulatory dataAbility to identify key changes, trends, and propose relevant insightsTechnical and Project Skills
Proficiency with regulatory intelligence databases and information systemsAbility to configure or optimize internal tools such as SharePoint, dashboards, or custom trackersGood project coordination skills with the ability to manage multiple workstreamsStrong communication skills, both written and verbal, for effective reporting and collaborationQualifications
Education & Experience
Bachelor's degree in life sciences, regulatory affairs, or a related field (Master's preferred)3–5 years of experience in regulatory affairs, regulatory operations, or related drug development rolesPreferred Background
Experience in regulatory intelligence or regulatory policy trackingFamiliarity with tools such as Tarius or other regulatory subscription databasesPrevious work in pharmaceutical or biotech industry with a global regulatory focusDemonstrated ability to understand and communicate regulatory impacts clearlySkills Required
regulatory intelligence , Regulatory Affairs, Data Analysis