Director/Senior Director, Regulatory Affairs & Submissions Management

Regulatory AffairsFull TimeUSA (Remote)

About the Role

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.

What You'll Do

Regulatory Strategy & Submissions

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

Health Authority Interactions

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

Regulatory Operations, Publishing & Compliance

Oversee the publishing, quality control, validation, and transmission of eCTD submissions to the US FDA (via the FDA ESG) and ensure compliance with regional technical and validation specifications for submissions in the UK, EU, Australia, and other jurisdictions
Perform and oversee in-house technical aspects of electronic submissions, including document granularity, template utilization, formatting, application lifecycle management, and dossier-level publishing
Perform and oversee quality control reviews of regulatory submissions prior to health authority filing to ensure packages are accurate, complete, and inspection-ready
Support the maintenance of Regulatory Information Management (RIM) and electronic document management systems, ensuring system integrity, governance, and user support
Establish and maintain standardized processes for document formatting, publishing workflows, submission validation, archiving, and audit-trail integrity in compliance with ICH GCP and applicable regional regulations
Act as hands-on Submission Manager for assigned programs: build and maintain submission trackers and milestone plans, coordinate document collection from cross-functional contributors, and personally drive day-to-day execution of the submission through to health authority transmission
Manage post-submission activities, including responses to regulatory queries and lifecycle maintenance of active applications
Follow applicable SOPs and client CRO handbooks and study plans

Lifecycle Reporting & Cross-Functional Leadership

Coordinate annual and periodic regulatory reporting for ongoing clinical development programs, including Development Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and study progress reporting, in partnership with internal and client teams
Coordinate cross-functional teams including regulatory, medical, clinical operations, biostatistics, data management, and quality assurance to deliver submission-ready deliverables on time
Provide regular status updates to internal stakeholders and client sponsors, and contribute to the continuous improvement of Regulatory Affairs and Submissions processes, tools, and documentation practices
Mentor and provide guidance to Regulatory Affairs staff

Qualifications

Bachelor's degree in life sciences, healthcare management, or a related field; an advanced degree (PhD, MS, PharmD, or equivalent) in life sciences, regulatory affairs, or a related field is preferred
Minimum of 5 years of regulatory affairs and/or submissions management experience in the pharmaceutical, biotechnology, or CRO industry
Demonstrated success submitting original INDs to the US FDA and CTAs in both the United Kingdom and the European Union, including original applications and amendments/substantial modifications
Hands-on experience with UK submissions through IRAS and EU submissions through CTIS
Working knowledge of ICH guidelines, FDA regulations, the EU Clinical Trials Regulation, UK HRA/MHRA requirements, and broader international regulatory frameworks
Excellent written and verbal communication skills, with the ability to interact effectively with senior executives, client sponsors, and regulatory agencies
Strong problem-solving and project management skills and the ability to manage multiple priorities in a fast-paced, client-facing environment
Demonstrated ability to operate at both ends of the regulatory spectrum: directing and overseeing submission strategy at the study level and personally executing the hands-on Submission Manager tasks of tracking, compiling, formatting, and transmitting submission packages

Nice to Have

Experience with publishing and validation of eCTD submissions for the US FDA
Experience with CTN submissions and HREC submissions in Australia
Experience with annual and periodic regulatory reporting, including DSURs, PBRERs, and PSPs (post-authorization safety studies / study progress plans), and other regulatory requirements for ongoing clinical development programs
Experience across multiple therapeutic areas and modalities, and prior CRO or client-facing regulatory experience
Relevant regulatory affairs certification (e.g., RAC) is a plus

Technology Skills

Proficiency with eCTD publishing and validation software (e.g., Lorenz docuBridge, DXC Toolbox, eCTDManager, or comparable) and eCTD viewers
Experience with Regulatory Information Management (RIM) systems and electronic document management systems
Familiarity with health authority submission gateways and portals (e.g., FDA ESG, IRAS, CTIS)
Proficiency with MS Word, Excel, PowerPoint, SharePoint, Adobe Acrobat, file management, and virtual meeting platforms

Details

Full time; 40 hours/week, overtime may be required on occasion
Travel: minimal; occasional travel for health authority meetings, client meetings, or conferences
Supervisory responsibilities: potential

How to Apply

Send your resume and a brief note about your regulatory submission experience, including the INDs, CTAs, and other applications you have led.

Apply Now

Pi Health is an equal opportunity employer.