Regulatory Affairs Associate

Bright Prospect; Selangor; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading firm in healthcare compliance is seeking a Regulatory Affairs professional to build relationships and manage compliance metrics. You will ensure effective communication between partners and internal teams, and assist in maintaining regulatory systems while supporting audits. Ideal candidates are those with a Bachelor's in a related field and 2-3 years of relevant experience. Strong communication, teamwork, and information technology skills are essential for this role based in Petaling Jaya, Selangor.

Qualifications

• 2-3 years of experience in Regulatory Affairs.
• Strong teamwork, communication, and negotiation skills.
• Good command of written and spoken English, and local language if applicable.

Responsibilities

• 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.
• Collaborate with stakeholders to define submission requirements and timelines.
• Assist in creating and maintaining registration plans in regulatory systems.
• Coordinate with global teams to gather documents and respond to authority queries on time.
• Submit documents to partners and maintain organized electronic archives.
• 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.
• 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.

Skills

Teamwork

Communication

Negotiation

Information technology proficiency

English proficiency

Education

Bachelor’s degree in a Scientific, Healthcare Science, or related field

Job description

Responsibilities

• 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.
• Collaborate with stakeholders to define submission requirements and timelines.
• Assist in creating and maintaining registration plans in regulatory systems.
• Coordinate with global teams to gather documents and respond to authority queries on time.
• Submit documents to partners and maintain organized electronic archives.
• 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.
• 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.

Qualifications

• Bachelor’s degree in a Scientific, Healthcare Science, or related field.
• 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.

Location: Petaling Jaya, Selangor

If you have what it takes, please send your resume to: Wei Li, Recruitment Consultant. Email: ********@brightprospect.com.my