About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, the company applies cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity.
You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com
Provide support to the regulatory affairs department to ensure maintenance and organization of regulatory files (electronic and paper) for proper tracking of information and archiving of regulated documents. The regulatory affairs intern will be involved in premarket, postmarket and compliance duties.
The intern will learn current skills for 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 areas of regulated document management.
- Facilitate the scheduling and running of monthly review meetings with APAC Affiliate RA teams. To assist in the stable implementation and 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.
- 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.
- Strong interpersonal skills, positive attitude, proactive approach to problem solving, reliable and outcome driven.
- Diploma or equivalent or higher
- Data processing experience or related office experience
- Proficient in Microsoft Office (especially Microsoft Excel)
- Understanding of pharmaceutical product terminology/lingo would be a plus
Please apply for this position by submitting your text CV using InternSG.
Kindly note that only shortlisted candidates will be notified.
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