Regulatory Affairs Specialist

1 day ago

Singapore beBeeRegulatoryAffairs Full time $80,000 - $120,000

We are seeking a highly skilled Regulatory Affairs professional to join our team. The Regulatory Affairs Executive will be responsible for managing the preparation and submission of regulatory documentation to health authorities in support of pharmaceutical product development, approval, and maintenance.

Key Responsibilities

  • Approving labels, packaging, and promotional materials for compliance with national and international regulations
  • Summarizing scientific data and preparing regulatory dossiers for new product approvals, renewals, and variations
  • Ensuring timely submissions to regulatory agencies and managing communication with health authorities
  • Tracking regulatory changes and reviewing product materials for compliance
  • Supporting clinical trials and maintaining regulatory databases

To be successful in this role, you should hold a Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field, along with 4-5 years of experience in pharmaceutical regulatory affairs. Strong knowledge of global regulatory requirements from FDA, EMA, ICH, CDSCO, etc., attention to detail, critical thinking, organizational skills, and excellent communication skills are essential.

Requirements

  • Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field
  • 4-5 years of experience in pharmaceutical regulatory affairs
  • Strong knowledge of global regulatory requirements
  • Excellent communication and organizational skills

This is a full-time position offering benefits such as cell phone reimbursement, day shift schedule, and a performance bonus.

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