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Associate Director of Regulatory Affairs
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- The Schrdinger regulatory team supports drug development through early clinical proof of concept and is responsible for regulatory strategy and operations.
- Key deliverables include developing regulatory strategy components of integrated development plans; coordinating interactions with global health authorities to obtain scientific advice; global regulatory submissions (including IND and CTA submissions); safety reporting; and annual regulatory maintenance activities.
- Schrdinger applies a proprietary physics-based drug design and optimization platform to the drug discovery process, which expeditiously advances assets into the clinic - making this a dynamic and high-paced work environment.
- We are seeking a highly motivated and experienced Associate Director / Director of Regulatory Affairs with expertise in hematology / oncology to join our Drug Discovery and Early Development team.
- The right candidate should be comfortable driving IND preparation, IMPD development; CTR compliant CTA applications (initial submissions and maintenance); managing health authority interactions (such as scientific advice meetings); orphan drug designation (ODD) submissions to the FDA and the EMA; and advising teams on asset strategy; indication strategy; clinical study designs and regulatory plans.
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