Position Description

Regulatory Affair Executive (Chemical Manufacturing | Tuas)
Job Code 18162
Division GMP RECRUITMENT SERVICES (S) PTE LTD (EA Licence:09C3051)
Job Placement Location Singapore
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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
  • Assess the impact of regulatory changes on the company; monitor, perform gap analysis and ensure timely and appropriate reactions to regulatory changes
  • 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

We regret to inform that only shortlisted candidate will be notified.
To apply, please visit to www.gmprecruit.com and search for Job Reference: 18162
To find out more about this opportunity, please contact Jaremy Ong at Jaremy.Ong@gmprecruit.com.
GMP Recruitment Services (S) Pte Ltd | EA Licence: 09C3051 | EA Personnel: Jaremy Ong | Registration No: R1876766

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