Director​/Senior Director, Regulatory Affairs & Submissions Management Regulatory Affairs Remote

Director/Senior Director, Regulatory Affairs & Submissions Management

Regulatory Affairs Full Time USA (Remote)

We are seeking an experienced Director, Regulatory Affairs and Submissions Management to join our Regulatory Affairs Department. This position serves as a senior regulatory leader responsible for developing and executing global regulatory submission strategies and for overseeing the operational excellence that brings those submissions to health authorities. You will act as a primary interface between Pi Health, our clients, and global health authorities, personally leading and hands-on supporting original clinical trial applications, amendments, and lifecycle maintenance across the US, UK, EU, and other jurisdictions on behalf of our biopharmaceutical clients.

This role combines Director-level oversight of regulatory strategy at the study level with the hands-on, execution-focused responsibilities of a Submission Manager. The ideal candidate is equally comfortable directing regulatory strategy across assigned studies and personally rolling up their sleeves to author, compile, format, quality-check, and transmit submission packages. They have a proven track record of successfully submitting INDs to the US FDA and CTAs in the UK and EU, managing CTNs and HREC submissions in Australia, are fluent in the technical demands of eCTD publishing and validation, and thrive in a fast-paced, client-focused environment where regulatory quality and speed are equally critical.

• 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

• Serve as a primary point of contact for health authority communications across assigned programs
• Draft, review, and submit regulatory correspondence including initial applications, amendments, meeting requests, and responses to information requests
• Manage regulatory meeting preparations, including briefing document development and post-meeting follow-up, and work closely with the Regulatory Project Management and Operations lead to maintain comprehensive health authority correspondence logs and tracking systems

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