Regulatory Assistant
at EPloyment Consultancy
Singapore, Southeast, Singapore -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 27 Jun, 2024 | Not Specified | 27 Mar, 2024 | 1 year(s) or above | Chemistry,Gmp,Life Science | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
- 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).
Interested applicants, please email your resume to us.
E-Ployment Consultancy
EA License No: 09C0884
EAP Name/ Registered No: Ivan Mah/ R110831
Responsibilities:
Please refer the Job description for details
REQUIREMENT SUMMARY
Min:1.0Max:6.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Diploma
Chemistry
Proficient
1
Singapore, Singapore