Director/Senior Director, Regulatory Affairs & Submissions Management
Sales & Business Development, Compliance / Regulatory
United States · Remote
Posted on Aug 22, 2026
- Direct and oversee regulatory submission strategy at the study level for Pi Health-run studies, aligning submission pathways and timelines with client sponsors and internal cross-functional teams, while personally executing submission-critical content and deliverables as needed
- Lead the preparation, compilation, and submission of original Investigational New Drug (IND) applications to the US FDA, including pre-IND interactions, and manage the full lifecycle of IND amendments and annual reporting submissions
- Lead CTIMP submissions in the United Kingdom through the Integrated Research Application System (IRAS), including initial applications and substantial modifications, in coordination with the HRA, MHRA, and Research Ethics Committees
- Lead CTA submissions in the European Union through the Clinical Trials Information System (CTIS) under the Clinical Trials Regulation (CTR) (EU) No 536/2014, including initial applications, additional Member State submissions, and substantial modifications
- Support Clinical Trial Notification (CTN) submissions and Human Research Ethics Committee (HREC) submissions in Australia as program needs require, and coordinate global regulatory submissions in other regions as needed
- Assess regulatory requirements across multiple global jurisdictions (FDA, MHRA, EMA, TGA, Health Canada, and others) and provide strategic guidance on regulatory risks, opportunities, and mitigation approaches
- Maintain current regulatory intelligence on evolving guidance, regulations, and agency best practices, and communicate the business impact of changes to program teams and clients
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