Regulatory Associate Trainee

Position: Regulatory Associate Trainee Experience: 0–1 year Location: Federal Territory of Kuala Lumpur, Malaysia Company: Navitas Life Sciences Company LimitedJob OverviewWe are seeking a motivated Regulatory Associate Trainee to join our team in Kuala Lumpur. This entry-level role is ideal for recent graduates or individuals with up to one year of experience who are eager to build a career in regulatory affairs within the life sciences industry.Key ResponsibilitiesGain a thorough understanding of regulatory submission requirements, including IND, ANDA, NDA, and DMF in CTD/eCTD formats for global regulatory bodies such as US FDA, EU authorities, and Health Canada.Support Regulatory Associates and Senior Regulatory Associates in document-level publishing, including bookmarking, hypertext linking, and preparing Tables of Contents in compliance with regulatory guidelines.Assist with submission publishing, archiving, and review of same-day dispatches, including major and complex submissions.Ensure strict adherence to client SOPs, internal policies and organizational procedures.Proficiency in Mandarin (reading, writing, speaking) is essential, along with the ability to translate from Mandarin to English.Educational QualificationsCandidates should hold one of the following degrees:Master of Computer Applications (MCA)Bachelor or Master of Science (B.Sc./M.Sc.)Bachelor or Master of Pharmacy (B.Pharm/M.Pharm)Bachelor or Master of Engineering (B.E./M.E.)Technical SkillsProficiency in MS Word, Excel, Access, PowerPoint, and Adobe ProfessionalNote: This position is open to Malaysian citizens only.