Position Description

Regulatory Affairs, Chemical Manufacturing (Tuas, ISO22716/GMP/Halal/CMC, $4.5K)
Job Code 18174
Division GMP RECRUITMENT SERVICES (S) PTE LTD (EA Licence:09C3051)
Job Placement Location Singapore
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  • Our Client is a well-established Firm, dealing with Health supplement products.

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 (e.g. 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 or Chemistry/Biochemistry/Biomedical Science/Cosmetic Science.
  • 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.

Other Information:

  • Working Location: Tai Seng (Company will shift Tuas in September 2021).
  • Working Hours: Mondays to Fridays, 9am to 6pm.
  • Critical: Due to the organization's affirmed support and commitment to developing a Singaporean core, this role is only available to Singaporeans.

To apply, please visit www.gmprecruit.com and search for Job Reference: 18174.
To learn more about this opportunity, please contact Novita Tan at novita.tan@gmprecruit.com
We regret that only shortlisted candidates will be notified.
GMP Recruitment Services (S) Pte Ltd | EA License: 09C3051 | EA Personnel: Novita Tan | Registration No: R1220374

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