GMP RECRUITMENT SERVICES (S) PTE LTD

Regulatory Affairs Executive (Up to $4,500)

GMP RECRUITMENT SERVICES (S) PTE LTD| Date Posted: 25-Apr-2021
EA Licence No: 09C3051|EA Personal Registration No: R1654652
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Job Nature:
Permanent
Position Level:
Experienced
Job Category:
Qualification:
Bachelor's / Honours

Job Description

Responsibilities:

  • Maintain comprehensive understanding and updated knowledge of the regional and international regulations and standards applicable to the company products and upkeep the relevant regulatory databases
  • Implement regulatory-related policies and standard procedures that are in accordance with applicable regulations and standards
  • Collaborate and maintain good relationships with external customers (including regulatory agencies, certification bodies, service providers, distributors, etc.)
  • Provide regulatory advice, develop, and maintain links to other teams (including quality, production, HQ’s regulatory affairs) so that appropriate development and quality plans may be established
  • Responsible for obtaining certification and compliance of the manufacturing site (eg. ISO22716, GMP, Halal, etc.) on a timely basis
  • Maintain business licenses and other authorities’ licenses for business operation
  • Assess the impact of regulatory changes on the company; monitor, perform gap analysis and ensure timely and appropriate reactions to regulatory changes
  • Assist in the implementation of optimal regulatory strategies to ensure regulatory and commercial success in the most effective and timely manner
  • To provide regulatory collaboration or undertake specific tasks in the project initiatives with cross-functional teams on technology transfer, CMC (Chemistry and Manufacturing Control), or other datasets for timely compilation
  • Responsible for tracking and supporting departmental QMS and related SOP, periodic reports, surveillance of new regulatory changes, etc.

Requirements:

  • Minimum Degree in Science, preferably in Chemistry / Biochemistry / Biomedical Science / Cosmetic Science or similar
  • 3 years of experience with the regulatory environment and in the Cosmetic, Health Food, Dietary Supplement, Pharmaceutical or other FMCG industry
  • Good understanding of global regulation – ACD, USFDA, TGA, EMA, ISO22716, PICs GMP, Halal, etc
  • Technical skills to guide cross functional teams on development requirements from a regulatory perspective.

More Information:

  • 5 days' work week, Monday to Friday, 9am to 6pm
  • Must be comfortable to work in Tuas area from August 2021 onwards

Please note that only shortlisted candidate will be notified.

 

GMP Recruitment Services (S) Pte Ltd | EA Licence: 09C3051 | EA Personnel: Jlynn Oh| Registration No: R1654652

Company Overview
GMP RECRUITMENT SERVICES (S) PTE LTD