Regulatory Affairs Associate Director / Director
Regulatory Affairs Associate Director / Director
Posted on :
29-08-2025
Employer Active
1 Vacancy
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Job Description
Job Description
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 (Masters 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: R1331018
Triton AI Pte Ltd
EA License Number: 21C0661
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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