regulatory affairs in Singapore

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job details

posted
location
singapore
specialism
life science
job type
permanent
reference number
90M0346090_1525675031
contact
jin quan jonathan soh, randstad
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job description

Duties:

  • Submits regulatory applications of LEO Products in Singapore and obtain timely approvals from Regulatory Authorities in the designated markets in South Asia
  • 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 (Parexel) 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 ensurecompliance 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

Requirements:

  • Degree in Science or Pharmacy
  • Based in Singapore currently
  • 2-3 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

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.