$100K — $150K *
• A minimum of 10 years of relevant experience in US regulatory affairs/drug development
• Experience in the coordination and preparation of document packages for regulatory submissions to ensure alignment and compliance with local and regional registration requirements as well as with company objectives
• Keeps abreast of US regulatory procedures and changes
• Assists with planning interactions with regulatory agencies in US, EU, Asia
• Extensive regulatory agency interactions and filing experience
• Extensive expertise with regulatory related development procedures (e.g., scientific advice, orphan designation, paediatric development plans, fast track, breakthrough).
• Global experience and/or knowledge of ICH regulations
• Ability to work independently is very important.
• Excellent communication skills
• Intercultural sensitivity
Valid through: 4/27/2021