Regulatory Intelligence Specialist
RegASK™
full-time
Posted on:
Location Type: Remote
Location: Remote • ⛩ Anywhere in Asia
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Manage the assignment of regulatory monitoring scopes across a global network of subject matter experts.
- Provide onboarding and continuous training to experts to ensure understanding of client requirements and content standards.
- Monitor expert performance, provide feedback, and maintain regular engagement to ensure alignment and accountability.
- Oversee the collection, review, and validation of regulatory alerts and sources, ensuring accuracy, consistency, and relevance to client scopes.
- Maintain high content quality and adherence to internal guidelines and delivery timelines.
- Support the operational execution & Client’s content set-up, ensuring smooth delivery through the platform.
- Collaborate with the tech team to improve content integration, tagging, and automation workflows.
- Contribute to the development and enhancement of the regulatory content database, including publishers and keyword tags.
- Ensure client scopes are accurately reflected in the monitoring workflow.
- Support ad hoc projects such as horizontal scanning, content analytics, special client requests, and regulatory affairs projects (e.g., compliance reviews, regulatory overviews), acting as a subject matter expert or project lead when required.
- Analyze existing workflows to identify gaps and inefficiencies and propose actionable solutions to improve operational efficiency.
- Support the development and refinement of training materials, standard operating procedures (SOPs), and quality control checklists.
- Drive ongoing process optimization initiatives to enhance team performance and content delivery.
Requirements
- Background in Regulatory Affairs, Quality, Life Sciences, Public Health or a related discipline.
- Education and or experience in Regulatory or Quality within the pharmaceutical and or medical device industries.
- Working knowledge of the pharmaceutical regulatory landscape in China, including the municipalities.
- Fluent in Mandarin and English, with strong written and verbal communication skills in both languages.
- Experience working with regulatory information or compliance centered workflows is an advantage.
- Strong attention to detail with the ability to review, organize, and manage high volumes of information.
- Comfortable collaborating with external experts and internal stakeholders, providing guidance and support where needed.
- Analytical thinker able to identify gaps, suggest improvements, and support process enhancements.
- Organized, proactive, and adaptable, with the ability to manage multiple priorities in a dynamic environment.
Benefits
- Flexible working arrangements (remote)
- An opportunity to drive impact at the intersection of AI, SaaS, and regulatory intelligence.
- Continuous learning and professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory monitoringcontent quality assuranceworkflow analysiscontent integrationdata validationtraining developmentprocess optimizationregulatory compliancecontent analyticsproject management
Soft skills
communicationattention to detailcollaborationanalytical thinkingorganizational skillsproactivityadaptabilityengagementfeedback provisionleadership