Regulatory Intelligence Specialist
Tailored Management
Regulatory Intelligence Specialist
We are seeking a detail-oriented and proactive Regulatory Intelligence Specialist to support the Regulatory Intelligence function through research, analysis, and operational support activities. This role is responsible for monitoring changes in the global regulatory landscape and ensuring timely communication of relevant insights to internal stakeholders.
Key responsibilities include:
- Monitor and track global regulatory developments, including health authority guidance updates, policy changes, and compliance requirements from agencies such as FDA, EMA, and other international regulatory bodies
- Conduct research using health authority websites, industry publications, databases, and other regulatory intelligence sources
- Collect, analyze, filter, and prioritize regulatory information relevant to ongoing development programs
- Prepare clear and concise regulatory intelligence summaries, reports, and briefings for cross-functional teams
- Track competitor regulatory activities, including product approvals, submissions, label updates, and pipeline developments
- Maintain and update regulatory intelligence databases, trackers, and knowledge management systems such as Veeva Vault or similar platforms
- Perform data entry, validation, and quality control checks to ensure data accuracy and completeness
- Organize and standardize regulatory information for efficient reporting and accessibility
- Support development and maintenance of dashboards, trackers, and reporting tools for leadership visibility
- Respond to ad hoc regulatory intelligence requests from internal stakeholders
- Collaborate with Regulatory Affairs, Clinical, and Program Management teams to align intelligence activities with business needs
- Ensure documentation is audit-ready, compliant, and properly maintained
- Identify process improvement opportunities and recommend enhancements to existing workflows and systems
- Utilize AI and digital tools, where applicable, to improve efficiency in data collection, summarization, and reporting
- Effectively manage multiple priorities and deadlines within a fast-paced, highly regulated environment
Vacancy posted 2 days ago
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