Regulatory Intelligence Specialist

We are seeking a detail-oriented Regulatory Intelligence Specialist to support regulatory intelligence activities through research, analysis, and operational execution. This role will be responsible for monitoring the evolving global regulatory landscape, identifying impactful regulatory developments, and delivering actionable insights to cross-functional stakeholders.

The ideal candidate combines strong research capabilities, regulatory knowledge, data management skills, and the ability to communicate complex information clearly within a highly regulated life sciences environment.

Key Responsibilities

• Monitor global regulatory developments, including health authority guidance updates, policy changes, and compliance requirements.
• Conduct structured research across regulatory agencies, industry publications, databases, and other relevant sources.
• Analyze, filter, and prioritize regulatory information based on business and development program impact.
• Prepare regulatory intelligence summaries, reports, presentations, and briefing materials for stakeholders.
• Track competitor regulatory activities, including approvals, submissions, label changes, and pipeline developments.
• Maintain regulatory intelligence databases, trackers, and knowledge management systems, including Veeva Vault or similar platforms.
• Perform data entry, validation, quality control, and record maintenance activities.
• Standardize and categorize intelligence data to improve accessibility and reporting.
• Support the development and maintenance of dashboards, metrics, and reporting tools.
• Respond to ad hoc regulatory intelligence requests from Regulatory Affairs, Clinical, and Program teams.
• Ensure documentation is audit-ready, traceable, and compliant with internal standards.
• Identify opportunities to improve workflows, processes, and reporting efficiency.
• Utilize AI and digital tools where appropriate to support information gathering, summarization, and reporting.

Required Qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs, Pharmacy, Public Health, Biotechnology, or a related discipline.
• Experience supporting Regulatory Affairs, Regulatory Intelligence, Clinical Development, Pharmacovigilance, or related functions within the pharmaceutical, biotechnology, or healthcare industry.
• Knowledge of global health authority regulations and guidance, including FDA, EMA, and other regulatory agencies.
• Strong research, analytical, and information management skills.
• Experience maintaining databases, trackers, or regulatory information systems.
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.

Preferred Qualifications

• Experience with Regulatory Intelligence platforms, Veeva Vault, or similar systems.
• Experience tracking competitor regulatory activities and industry developments.
• Familiarity with dashboard creation, reporting tools, and data visualization.
• Experience leveraging AI-enabled tools for research and information management.
• Knowledge of drug development and regulatory submission processes.