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Regulatory Assistant

3 months ago

Singapur, Singapore E-Ployment Consultancy Full time
Coordinate with laboratory, production and other relevant departments to gather registration requirements.
Coordinate with customers on registration requirements.
Arrange endorsement for regulatory documents.
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.
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.
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.

Job Requirements:

Diploma holder in life science, pharmacy, chemistry or related courses.
1 year experience in GMP (Good Manufacturing Practice) and CTD (Common Technical Document) preparation.
Knowledge of GMP or major international regulatory such as ICH.
5 day work week (Office hours).

E-Ployment Consultancy
EA License No: 09C0884
EAP Name/ Registered No: Ivan Mah/ R1108310