Regulatory Affairs Professional

2 days ago


Singapore beBeeRegulatory Full time
Regulatory Affairs Specialist
Job Overview
We are seeking a highly organized and detail-oriented Regulatory Affairs Specialist to assist in the planning, execution, and maintenance of regulatory activities for clinical trials and marketing authorisation. This role will work closely with cross-functional teams to ensure compliance with relevant regulations and guidelines.
Responsibilities
  • Support the submission of applications and variations for clinical trials and marketing authorisation across all pipelines.
  • Conduct regulatory assessments of submission requirements based on relevant regulations and provide recommendations for improvement.
  • Perform administrative tasks necessary to support regulatory activities, including document management and data entry.
  • Review and provide input on regulatory documents, ensuring accuracy and completeness.
  • Collaborate with internal stakeholders to identify and address regulatory risks and opportunities.
Qualifications
  • Bachelor's degree in Biological, Chemistry, or a related field.
  • No prior experience required, but a strong interest in Regulatory Affairs is essential.
  • Excellent analytical and problem-solving skills, with a keen attention to detail and organizational abilities.
  • Proficiency in English (written and spoken) is mandatory.


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