Job Description

More than just a recruitment company. At PRTR, we have been a part of our customer's success for 30 years as their total HR solutions partner. With 550 dedicated professionals and over 15,000 outsourced staff, we will continue to carry out our mission to develop a better career, a better life, and a better society, and thrive to become the No.1 people solutions organization in Southeast Asia.

Position Purpose

The Regulatory Affairs Executive manages various regulatory activities, including strategic planning, package submission, registration amendments, report preparation, approval obtaining, GMP clearance, product license maintenance, and product license withdrawal. Additionally, he/she is responsible for supporting packaging artwork for registered products and ensuring compliance with relevant regulations and company SOPs.

Primary Responsibilities

• Project Management:

• • Developing and implementing regulatory project plans, ensuring alignment with stakeholders, project objectives, and regulatory requirements.
  • Coordinating cross-functional teams to achieve project milestones and deadlines.
  • Monitoring project progress, updating trackers, identifying potential risks, and implementing mitigation strategies.

• Regulatory Submissions:

• • Preparing and submitting regulatory documents to Health Authorities, ensuring accuracy and compliance with local and international regulations.
  • Reviewing and approving submission packages, ensuring completeness and consistency.
  • Maintaining up-to-date knowledge of regulatory requirements and guidelines.

• Stakeholder Communication:

• • Serving as the primary point of contact for regulatory project-related inquiries.
  • Communicating project status, updates, and issues to internal and external stakeholders.
  • Collaborating with other departments to ensure alignment and knowledge transfer.

• Compliance and Documentation:

• • Ensuring all regulatory documents are stored and managed following company SOPs and regulatory requirements.
  • Tracking and managing regulatory commitments, ensuring timely completion and notification to Health Authorities.
  • Maintaining Regulatory Affairs Compliance Files consistent with local Health Authorities' or company expectations.

• Audits and Inspections:

• • Participating in and supporting regulatory audits and inspections as required.
  • Implementing corrective and preventive actions (CAPAs) to address audit findings.

• Health Authority Engagement:

• • Monitoring and reporting on external developments in regulatory requirements and expectations.
  • Engaging with Health Authorities and industry associations to stay informed of regulatory changes and initiatives.

• Additional Assignments:

• • Assisting managers with additional assignments and projects as needed.
  • Providing support for other regulatory activities as required.

Qualifications

• Doctor of Pharmacy.
• 2–3 years of experience in Regulatory Affairs.
• Fluent in English – writing, speaking, and listening skills.