Kyowa Kirin Asia Pacific Pte. Ltd. – Intern, Regulatory Affairs

Kindly note that only undergraduates based in Singapore can be candidates for this position.

JOB PURPOSE

Provide support to the regulatory affairs department through careful compilation of requirements for regulatory submissions; and close coordination with relevant stakeholders to meet these requirements.

Ensure maintenance and organization of regulatory files (electronic and paper) for proper tracking of information and archiving of regulated documents.

This position will be involved in premarket, postmarket and compliance duties.

The intern will learn project management skills and file management in electronic systems. He/she will gain experience in project start, execution and completion in the pharmaceutical field that will be broadly applicable in other fields where regulatory compliance is required. At the same time, the intern will benefit from the pharmaceutical science and drug regulatory knowledge gained throughout the period.

KEY RESPONSIBILITIES

• Support the preparation and collation of high quality documentation for assigned regulatory submissions.
• Aid in the liaison with relevant internal departments and/or stakeholders to meet the regulatory requirements for the assigned submissions.
• Participate in discussions to support the resolving of complex regulatory issues.
• Facilitate the scheduling and running of monthly review meetings with APAC Affiliate RA teams.
• To assist in the stable operations of regulatory information management (RIM) system and regulatory archiving system (GRAPES4).
• Day-to-day operations within the company’s RIM system for stable operation of its existing functionalities that mainly deals with archiving of dossiers. Responsibilities include
  • helping to enable users to import dossiers, and also importing & exporting of any dossiers for users who are unable to access the RIM system.
  • helping users to familiarise with the RIM system’s new functionality that allows users to manage and track product registrations and registered product details in each market.
  • Creating archive or submission sequences within the system to allow users to upload approved documents or documents authored for submission; and verifying completeness of uploads and maintaining necessary tracking database
• Perform other tasks as needed related to regulatory affairs/regulatory operations.

POSITION REQUIREMENTS

Skills/qualifications:

• Demonstrates interest in the regulatory environment surrounding drug development and drug premarket/ postmarket applications.
• Good written and communication skills.
• Strong attention to detail and demonstrated personal or professional experience with information handling and retrieval.
• Comfortable working and contributing in cross-functional project teams. Have strong interpersonal skills, positive attitude, proactive approach to problem solving, reliable and outcome driven.

Educational requirements:

• Undergraduate or Postgraduate of Diploma or equivalent or higher in University located in Singapore
• Data processing experience or related office experience
• Proficient in Microsoft Office (especially Microsoft Excel)
• Prior knowledge of pharmaceutical science and/or drug regulations would be a plus.

SUPERVISION PLAN

• Mentor assigned to every intern with weekly one-to-one sessions on learning progress.
• Planned onboarding and on-the-job training sessions.
• Assignment and guidance from projects owners to the intern, with the aim to gain experience of relevant work skills.