Salary: 4500 - 6000 SGD / month

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Job content

  • Evaluate regulatory risks of Medical Business division policies, processes, procedures
  • Develop new regulatory policies, processes and SOPs in Medical Business and train key personnel
  • Prepare and maintain technical documentation packages to ensure regulatory requirements for product registration submissions to competent authorities are met in regional countries
  • Update, renew and maintain document control system, including registration documents, files, records of new and existing product portfolio
  • Monitor impact of changing regulations and update internal stakeholders
  • Oversee processes involved with maintaining annual licenses, registrations, listings and import/export controls
  • Review and approve advertising and promotional items to ensure regulatory compliance and ensure external communications meet regulations in Medical Business
  • Provide regulatory input for product recalls and recall communications
  • Coordinate and implement quality system standards required
  • Responsible for proper documentation of internal and external audits
  • Assist management in the implementation and maintaining of regulatory system; legal and compliance issues pertaining to quality management system
  • Compile all regulatory data and framework to educate relevant / related stakeholders
  • Other duties and projects, as assigned
  • Min. Degree in Pharmacy, Pharmacology, Biology or any related subject.
  • Min. 2 years Regulatory Affairs experience in the Medical Device / Pharmaceutical Industry.
Interested applicants please email a detailed resume in Word document to:
[email protected]
Subject: Senior Regulatory Affairs Executive
or call 67363280 and ask for Joshua.
EA Personnel: Koh Zhi Sheng, Joshua (R2091112)
Company EA Registration: 99C4599
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Deadline: 20-07-2023

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