<div>Company introduction: 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. - <a href="https://compasspathways.com/">Compass Pathways</a>.</div>Job Overview: The Senior Manager, Regulatory Affairs will be a strategic thinker, responsible for researching and assessing regulatory precedence and contributing to regulatory strategies for development of Compass Pathways investigational drug programs. As assigned, this individual will be responsible for application maintenance activities, amendments, supplements, regulatory intelligence activities, and other policies and procedures. This position assists in maintaining organization’s Regulatory Affairs operational functions and direct lines of communication for, interactions with, and access to Regulatory Authorities/Agencies in the US and abroad, in compliance with regulatory guidance, regulation and laws. This position is a generalist role and will be part of a regulatory team. The individual will have collaborative and leadership skills to allow for successful cross functional interactions with the organization. Location: Remote on the East Coast in the United States or hybrid in our New York City office. Reports to: Senior Director, Regulatory Affairs Roles and Responsibilities: (includes but are not limited to) <ul> <li>Supports the execution of regulatory strategies and implementation plans for the preparation and submission of investigational and new drug applications, amendments, investigator filings, annual reports, and associated labelling</li> <li>Manages assigned regulatory communications and assists with preparation activities for Agency meetings, responses to Agency requests, and pre-meeting packages to ensure the organization complies with applicable regulation and guidance</li> <li>Manages regulatory intelligence process – monitors for new or changing regulations and coordinates internal stakeholders to ensure development of strategies to address applicable changes</li> <li>Supports management of regulatory applications to ensure compliance with regulations, including tracking of submission timelines, coordination of authoring and review of submission deliverables, and proactive identification and communication of delays and risks</li> <li>Acts as a regulatory representative on assigned project teams, providing regulatory guidance and recommendations in line with company goals, applicable laws and regulations, and the overall regulatory strategy</li> <li>Liaises with the Regulatory Operations team to coordinate publishing activities and timelines for assigned submissions</li> <li>Conducts regulatory research in relation to assigned programs and disseminates relevant information to management and cross-functional teams</li> <li>Performs other regulatory responsibilities/duties as assigned by the Senior Director, Regulatory Affairs</li> </ul> Candidate Profile: <ul> <li>Considerable regulatory experience in a CRO/biotech/pharmaceutical company</li> <li>BSc degree in relevant/related discipline/industry required, advanced degree a plus</li> <li>Experience in CNS/psychiatric therapeutic area a plus</li> <li>Extensive experience with Microsoft Word and PowerPoint, Adobe Acrobat; familiarity with SharePoint, ISI Writer and/or similar common pharma/biotech industry applicable platforms; Microsoft Project experience a plus</li> <li>Experience in interpretation of regulations, guidelines, policy statements, etc</li> <li>Experience and knowledge in the preparation of regulatory submissions, including amendments or supplements</li> <li>Strong attention to detail and the ability to manage multiple tasks</li> <li>Collaborative attitude and willingness to work in a cross-cultural environment</li> <li>Ability to work in a fast pace and dynamic atmosphere</li> <li>Adaptive thinking and “can-do” spirit</li> <li>Strong team player and communicator - proactive planner and solutions oriented</li> <li>Ability to work both independently with minimal supervision and within a matrix management structure</li> <li>Experience working with third party vendors, consultants and external partners</li> </ul><div><div><div>【For NYC】Compensation Description (annually): Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity.</div><div>【Base salary per annum】:</div><div>$166,000—$215,000 USD</div></div></div><div><h2>Benefits &amp; Compensation:</h2> For an overview of our benefits package and compensation information, please visit  <a href="https://compasspathways.com/join-us/">Working at Compass</a>.   <h2>Equal opportunities:  </h2> Reasonable accommodation We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know.  UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. <h2>Sponsorship:</h2> Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. <h2>Data Privacy:</h2> All data is confidential and protected by all legal and data privacy requirements, please see our recruitment <a href="https://compasspathways.com/recruitment-candidates-privacy-notice/" target="_blank">Privacy Notice</a> to learn more about how we process personal data.</div>

COMPASS Pathways

Senior Manager, Regulatory Affairs

COMPASS Pathways

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