Role & Responsibilities:
· Prepare registration documents according to country specific guidelines for submission to legislation authorities.
· Consolidate and compile raw data, reference information and product technical specifications.
· Assist in the preparation of GMP related requirements
· Coordinate with laboratory, production and other relevant departments to gather registration requirements.
· Coordinate with customers on registration requirements.
· Arrange endorsement for regulatory documents.
· Liaise with relevant authorities (NEA, SCDF, SPF, HSA and MOM) on licensing, compliance and other legislative matters.
· Evaluate new products if license is required according to local regulations.
· Prepare Safety Data Sheet (SDS) and GHS labels in accordance to Globally Harmonized System (GHS) standards.
· Manage registration sample requests, receipts and dispatch by proper recording and monitoring and storage.
Role Requirements:
· Diploma / Nitec in life science applied Chemistry, Biomedical Science, Biotechnology or any other science or chemistry related discipline
· At least 1 year experience in GMP (Good Manufacturing Practice) and CTD (Common Technical Document) preparation
· Knowledge of GMP and major international regulatory requirements such as ICH
· Good communication skills in English (written and spoken)
· Able to do research and write technical documents
· Good analytical and problem-solving skills
Working Hours:
· Monday – Friday: 8.15am-5.30pm
Benefits:
· Transport provided at Lakeside & Boon Lay MRT station
· Medical Insurance upon confirmation
· AWS and profit sharing upon eligibility
