Regulatory Affairs Associate

Location: Petaling Jaya, Selangor

Job Descriptions:

Stakeholder Collaboration

• Build and maintain working relationships with external partners and internal teams.
• Ensure alignment of regulatory plans, address issues promptly, and monitor performance metrics.
• Serve as the primary point of contact for regulatory inquiries from partners and internal stakeholders.

Regulatory Planning

• Collaborate with stakeholders to define submission requirements and timelines.
• Assist in creating and maintaining registration plans in regulatory systems.

Dossier Management

• Coordinate with global teams to gather documents and respond to authority queries on time.
• Submit documents to partners and maintain organized electronic archives.

Labeling

• Ensure compliance with global labeling procedures and handle exceptions as needed.
• Initiate labeling projects and coordinate with teams to deliver updated packaging materials on schedule.

Regulatory Compliance

• Maintain accurate data in regulatory systems and follow compliance metrics.
• Support audits, inspections, and corrective actions as required.
• Share key compliance updates and conduct impact assessments for management and relevant teams.

Job Requirements:

• Bachelor’s degree in a Scientific, Healthcare Science, or relevant.
• 2-3 years of experience in Regulatory Affairs
• Strong teamwork, communication, and negotiation skills to build positive relationships internally and externally.
• Proficient in information technology.
• Good command of written and spoken English, and local language if applicable

Others Information:

For those who have what it takes, please send in resume to:
Recruitment Consultant: Wei Li
Email: weili@brightprospect.com.my