Regulatory Assistant

3 weeks ago


Singapur, Singapore E-PLOYMENT CONSULTANCY Full time
Roles & Responsibilities

  • 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 jobs@e-ployment.com.sg


E-Ployment Consultancy

EA License No: 09C0884

EAP Name/ Registered No: Ivan Mah/ R1108310


Tell employers what skills you have

Licensing
Cell
Derivatives
Due Diligence
Labels
Outsourcing
Legislation
Vetting
GMP
Assurance
Chemistry
Internal Controls
Appeals
Laboratory
Manufacturing
Conflict
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