Regulatory Affairs Associate Director / Director

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.

Registration Number: R

Triton AI Pte Ltd

EA License Number: 21C0661