Global Regulatory Affairs Specialist

1 week ago

Singapore beBeeRegulatory Full time $80,000 - $120,000
Regulatory Operations Role">

The successful candidate will be responsible for overseeing the day-to-day activities and deliverables associated with global regulatory submission / dossier publishing.

This includes compilation and maintenance of regulatory documentation, performing high-level file formatting using client-provided software, and peer-reviewing work to ensure quality standards are met.

Additionally, the individual will interact with relevant stakeholders during report preparation and quality control, as well as provide support to other regulatory-related activities.

Requirements">

Applicants must hold a degree in Science, Computer Science, or Engineering, and possess at least one year of experience in the pharmaceutical industry, medical device field, or related industry.

Relevant experience in regulatory affairs is highly advantageous.

Key Skills and Qualifications">
  • Science, Computer Science, or Engineering degree
  • Minimum 1 year of experience in pharmaceutical industry / Medical Device / any related industry (preferably relevant experience in regulatory affairs)
Desirable Skills">
  • Pharmaceutical Industry
  • Annual Reports
  • Microsoft Excel
  • Derivatives
  • Quality Control
  • Due Diligence
  • Regulatory Compliance
  • Outsourcing
  • Vetting
  • Regulatory Affairs
  • Assurance
  • Documentation Skills
  • Internal Controls
  • Surveillance
  • Publishing
  • Appeals
  • Life Sciences
  • Regulatory Submissions
  • Conflict
  • Business Requirements

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