Position: Regulatory Associate Trainee
Experience: 01 year
Location: Federal Territory of Kuala Lumpur, Malaysia
Company: Navitas Life Sciences Company Limited
Job Overview
We 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 Responsibilities
- Gain 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 Qualifications
Candidates 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 Skills
- Proficiency in MS Word, Excel, Access, PowerPoint, and Adobe Professional
Note: This position is open to Malaysian citizens only.
