Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments.

We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area.

We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways.

Compass is seeking a highly motivated and experienced Director, Regulatory Project Management to lead the end-to-end project management of a New Drug Application (NDA) submission. This individual will ensure that all activities are strategically planned, efficiently executed, and delivered on time, within scope, and to the highest quality standards.

Location: Hybrid in our New York City office or remote on the East Coast, USA.

Reports to: Senior Vice President, Regulatory Affairs.

Duration: 12 months contract.

Include but are not limited to:

Submission Leadership: Develop, implement, and maintain a comprehensive NDA submission project plan, including detailed timelines, workstreams, milestones, and dependencies. Drive the overall project plan for NDA preparation and submission, ensuring all components are planned, tracked, and delivered on schedule. Define the critical path activities and proactively adjust plans in response to evolving requirements or risks. Align submission activities with overall development program strategy and corporate objectives. Partner with Regulatory Strategy and Operations leads to translate high-level regulatory strategy into detailed, executable submission plans.

Governance & Oversight: Establish appropriate submission governance forums (e.g., core team, functional sub-teams, steering committee, etc.). Define decision-making process and escalation pathways to ensure effective risk and issue management. Facilitate effective cross-functional working sessions to maintain alignment and momentum. Provide regular status updates, metrics, and dashboards to cross-functional teams, management and executive leadership.

Execution & Deliverable Management: Drive collaboration across Clinical, CMC, Nonclinical, Clinical Pharmacology, Safety, Statistics, and Medical Writing, to ensure alignment of deliverables. Track document authoring, review, and finalization cycles, providing clear visibility of status across teams, to ensure CTD content is delivered on schedule. Partner with regulatory operations to oversee dossier compilation, QC, and submission readiness. Serve as the central point of contact for submission progress and status inquiries.

Risk, Issue & Change Management: Proactively identify risks to submission timelines and establish mitigation and contingency plans. Maintain a risk register and ensure issues are tracked, escalated, and resolved in a timely manner. Manage changes in priorities or scope while preserving overall submission objectives.

Operational Excellence: Develop and maintain detailed timelines, trackers, and dashboards to drive execution against critical path activities. Support Regulatory Operations efforts in publishing, document management, and inspection readiness with internal teams and external vendors. Ensure adherence to SOPs while introducing pragmatic process improvements where gaps exist. Develop, maintain, and monitor detailed submission project plans, including critical path analyses and contingency planning. Ensure adherence to company standard operating procedures (SOPs), templates, and regulatory publishing requirements. Support inspection readiness and documentation of submission-related activities.

Health Authority Engagement: Develop and oversee project plans and timelines for FDA interactions related to the NDA submission, including briefing packages, meeting logistics, and response management. Ensure all submission components meet regulatory agency requirements and withstand internal/external audit scrutiny.

Post-Submission Transition: Establish mechanisms to track submission-related milestones, commitments, and queries from FDA (e.g., Labeling, REMS, IRs, etc.). Develop and oversee response authoring timelines for FDA submission-related queries. Transition governance from submission execution to lifecycle management and post-approval commitments.

Bachelor's degree in life sciences, pharmacy, or related discipline required; advanced degree (MS, PharmD, PhD, or MBA) preferred. 10+ years of experience in the pharmaceutical/biotech industry, with significant experience in regulatory project management. Demonstrated leadership in managing at least one NDA or BLA submission from initiation through completion; experience managing rolling and/or expedited reviews is a plus. Deep knowledge of FDA regulations, ICH guidelines, and CTD/eCTD structure. Proven ability to manage complex, multi-disciplinary projects under tight timelines. Proficiency with project management methodologies and tools (e.g., MS Project, Smartsheet, Veeva Vault RIM, or equivalent). Strong organizational, analytical, and facilitation skills, with an ability to influence across functions and levels.

Base salary per annum: $225,000 - $275,000 USD. Base salary range is a guideline, with total compensation varying based on qualifications, skill level, competencies, and work location. Additional discretionary bonuses and equity are available regardless of location.

For an overview of our benefits package and compensation information, please visit "Working at Compass" on the company website.

Compass Pathways is committed to diversity, equality, and reasonable accommodation during the interview process. The company does not discriminate based on protected characteristics and provides equal opportunity employment in compliance with laws in the UK and US.

The company cannot sponsor employment visas and can only accept applications from candidates with employment rights in the country of application.

All data is confidential and protected by legal and data privacy requirements. Refer to the company's recruitment Privacy Notice for details on data processing.