regional regulatory affairs specialist in Singapore

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job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
reference number
90M0346090_1536143161
contact
jin quan jonathan soh, randstad
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job description

An established European pharmaceutical MNC is looking for a Regional Regulatory Affairs Specialist to join their ranks!

Duties:

  • Submits regulatory applications of company 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
  • Minimum 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

Interested applicants can also email to jonathan.soh@ randstad.com.sg



skills

regulatory, registration, pharmaceutical

qualification

-

educational requirements

Bachelor Degree