
Regulatory Affairs Associate Director
1 day ago
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.
- 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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