regulatory affairs specialist (contract) in Singapore

jin quan jonathan soh, randstad
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job details

life science
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jin quan jonathan soh, randstad
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job description

about the company
An established European pharmaceutical company with over 100 years of history

about the job

Regulatory Affairs (RA)

  • Prepares and submits regulatory applications and keeps product registration files updated
  • Keeps track of all registration activities including Marketing Authorization Applications (MAAs), Marketing Authorization Renewals (MARs) and Marketing Authorization Variations (MAVs)
  • Works closely with Corporate Regulatory Affairs (cRA), Sourcing Partner and local Regulatory Partners on registration matters
  • Keeps abreast of updated regulations in the region via close communication with local Regulatory Partners
  • Supports local Regulatory Partners to negotiate and liaise with local Regulatory Authorities to expedite early regulatory approvals while developing and pursuing excellent working relationships
  • Manages labeling text and packaging components to ensure compliance with local regulatory guidelines and corporate prescribing information requirements
  • Ensures proper documentation of all registration applications and communications with Regulatory Authorities, while adhering to Regulatory Affairs working procedures and SOPs

SIMBA (Product Quality Complaints)

  • User of SIMBA Module for Product Quality Complaints
  • Any other adhoc duties as assigned by immediate manager

about the manager/team
This role reports in to the Head of South Asia regulatory affairs based in Singapore

skills and experience required

  • Degree in Science or Pharmacy
  • 1-2 years of regulatory experience in a pharmaceutical environment
  • Familiar with the regulatory framework in Singapore.
  • Working knowledge of regulatory procedures and submissions in other Asian markets would be an advantage
  • Able to work independently and also be a team player
  • Self motivated to accomplish performance objectives

To apply online please use the 'apply' function, alternatively you may email Jonathan at jonathan.soh@
(EA: 94C3609/R1656945)


no additional skills required


no additional qualifications required

educational requirements

Bachelor Degree