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wellous group

Regulatory Affairs Assistant Manager

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  • Posted 8 days ago
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Job Description

Key Activities

  • To act as the point of contact of all Regulatory Affair (SCR) matters for all regional countries where the group of companies operates.
  • To lead, manage and obtain approvals of all Product Registration and ensuring that the products of the entire group of companies comply with the regulations of respective Asian Region countries.
  • To lead and liaise with the FDA in the respective Asian Region countries on product registration, determining HS codes, labelling, and any other related regulatory inquiries.
  • To keep abreast of international legislation, guidelines, and customer practices
  • To be well versed with the requirement and development as well as follow up on any local food regulatory licenses and applications including but not limited to HALAL, HACCP and so on for the group of companies.
  • Participate in continuous improvement activities within the department, and propose process enhancements to improve submission efficiency and accuracy
  • To maintain complete database of registration requirements, status/expiry dates, renewal deadlines, etc for domestic and regional countries.
  • To maintain product licenses validity and to apply for re-registration when necessary.
  • To perform any ad-hoc tasks assigned by Head of Product Development from time to time.

Job Requirement

  • At least 5 years of Science & Regulatory Affairs relevant working experience in healthcare industry.
  • Updated knowledge on Asian Region product regulatory requirements would be an added advantage.
  • Excellent written and verbal communication skills.

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About Company

Job ID: 146120531

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