Global Regulatory Affairs Specialist

1 week ago

Singapore beBeeRegulatory Full time $80,000 - $150,000

Regulatory Operations Executive Job Description

We are seeking an experienced Regulatory Operations Executive to join our team. In this role, you will be responsible for managing the day-to-day activities and deliverables related to global regulatory submissions and dossier publishing.

Key Responsibilities:
  • Compilation and maintenance of regulatory documentation as per established procedures in client repositories.
  • Performing high-level formatting of files using client-provided software, including creating bookmarks, hyperlinks, and file optimization.
  • Peer-review of work and providing support to other regulatory-related activities as per business requirements.
  • Interacting with stakeholders during preparation and quality control of reports and regulatory documentation.

Requirements:

  • A degree in Science, Computer Science, or Engineering.
  • A minimum of 1 year of experience in the pharmaceutical industry, medical device industry, or a related field (preferably with 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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