Regulatory Affairs Professional

2 weeks ago

Singapore beBeeRegulatory Full time $60,000 - $100,000
Job Title: Regulatory Affairs Professional

This role will be responsible for all domestic and regional regulatory affairs, including New Drug Applications (NDAs), variations and registration renewals in Singapore and Asian countries.

The ideal candidate will establish domestic and regional pharmacovigilance for products, ensuring compliance with the Food and Drug Administration (FDA) and other agency laws and regulations.

Key Responsibilities:

  • Prepare and document regulatory submissions to government agencies
  • Monitor FDA and other agency laws and regulations, providing recommendations and assistance to ensure company compliance
  • Direct certification application activities, including sending and tracking certification letters
  • Provide metrics for regulatory management reporting and identify areas for further monitoring
  • Track global registration status for project teams and new products

Requirements:

  • Bachelor's degree in a science-related field such as pharmacy, chemistry or biology
  • Minimum 2-3 years of experience in domestic and regional regulatory affairs
  • Familiarity with regulatory affairs such as NDA, variation, and renewal of product registrations in the Pharmaceutical industry
  • Pharmacovigilance experience preferred but not mandatory

Skillset:

  • Project strong initiatives to establish operating procedures for a new start-up organization
  • Detail-mindset, responsible, well-organized
  • Strong communication and interpersonal skills in a shared office environment
  • Pro-active and positive mindset

We are seeking an experienced Regulatory Affairs Specialist who can maintain our high standards while ensuring we remain compliant. The ideal candidate should have a solid understanding of regulatory requirements and laws within Asia and be able to navigate various local authorities efficiently.

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