Regulatory Assistant

3 days ago

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

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