Regulatory Affairs Associate Director

1 day ago


Singapore TRITON AI PTE LTD Full time
Regulatory Affairs Associate Director / Director

1 week ago Be among the first 25 applicants

Responsibilities
  • Manage the entire process of getting new drugs approved in the US and EU, from initial research all the way through post-market changes.
  • Develop and evaluate submission documents covering key administrative, summary, and clinical data, maintaining strict adherence to ICH and local regulations.
  • Communicate directly with regulatory agencies like the FDA, EMA, and MHRA to handle questions, inspections, and label discussions.
  • Help develop and carry out registration plans for new markets in regions like Southeast Asia (ASEAN) and the Middle East/North Africa (MENA).
  • Work closely with different teams (like manufacturing and clinical research) to make sure all submitted information is scientifically sound.
Requirements
  • Advanced degree (Master's or PhD) in Pharmacy, Biology, or a related discipline.
  • Over 5 years of international regulatory affairs experience, having led at least two successful FDA or EMA drug approvals from initiation to completion.
  • Skilled in electronic submission platforms (e.g. Veeva RIM)
  • Specialized in registering vaccines and biologics, covering areas such as influenza, COVID-19, and HPV.
  • Previous experience as a reviewer or regulator at FDA, EMA, or MHRA is advantageous.
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