Regulatory Intelligence Specialist

RegASK; Batu Pahat; Remote; MYR 60,000 - 80,000; Full time

Job summary

A global regulatory intelligence firm based in Malaysia is seeking a Regulatory Intelligence Specialist to enhance their compliance operations. This individual will manage regulatory information workflows, collaborate with a network of experts, and ensure content quality across global markets. Candidates should possess a background in Regulatory Affairs or related disciplines and be fluent in Mandarin and English. This role offers flexible working arrangements and opportunities for professional development.

Benefits

Flexible working arrangements

Continuous learning opportunities

Qualifications

• Experience working with regulatory information workflows is an advantage.
• Comfortable collaborating with external experts and internal stakeholders.
• Proactive and adaptable in dynamic environments.

Responsibilities

• Manage regulatory monitoring scopes and expert assignments.
• Oversee quality of regulatory alerts and ensure accuracy.
• Support content integration and collaborate with tech teams.
• Conduct process improvement initiatives and propose solutions.

Skills

Fluent in Mandarin

Strong communication skills in English

Attention to detail

Analytical thinking

Ability to manage multiple priorities

Education

Background in Regulatory Affairs, Quality, or Life Sciences

Experience in pharmaceutical or medical device industries

Job description

RegASK is an AI-driven solution enabling end-to-end intelligent regulatory workflow orchestration: automating regulatory intelligence with curated content and actionable insights, smart documentation and a connected community of over 1,700+ subject matter experts for streamlined regulatory execution globally. RegASK augments Regulatory Affairs teams, combining AI efficiency and community-driven intelligence to streamline compliance across the product lifecycle. The RegASK team is highly diverse, with more than 10 nationalities across 3 continents, entrepreneurial and very agile. We are currently recruiting highly motivated individuals to expand its team and support its ambitious growth plans.

If you are a doer who enjoys working across industries and continents, autonomous in your working style, and eager to problem solve, we would love to hear from you.

POSITION OVERVIEW

RegASK is seeking a Regulatory Intelligence Specialist who is meticulous, organized, and confident in managing regulatory information workflows across global markets. You will coordinate closely with a network of subject matter experts, oversee the quality and relevance of regulatory content, and ensure that client requirements are accurately reflected throughout the monitoring process.

This position is ideal for someone who enjoys working with diverse stakeholders, ensuring clarity and consistency in content delivery, and supporting the broader regulatory intelligence function in a fast moving environment.

Key Responsibilities

Scope & Expert Management:

• 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.

Content Oversight & Quality Assurance:

• 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.

Platform and Workflow Operations:

• 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.

Client and Internal Collaboration:

• 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.

Process Improvement:

• 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.

Qualification & Experience

• 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.

What We Offer

• Flexible working arrangements (remote)
• An opportunity to drive impact at the intersection of AI, SaaS, and regulatory intelligence.Continuous learning and professional development

How to Apply

If you are excited about this opportunity and believe you have the skills and qualifications to excel as our Regulatory Intelligence Specialist, please submit your resume for our consideration.

We appreciate all applications, but only selected candidates will be contacted for an interview.

Thank you for considering joining the RegASK team. We look forward to reviewing your application!