Regulatory Assistant

at  EPloyment Consultancy

Singapore, Southeast, Singapore -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate27 Jun, 2024Not Specified27 Mar, 20241 year(s) or aboveChemistry,Gmp,Life ScienceNoNo
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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