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)

• 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
• 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
• Manages regulatory intelligence process – monitors for new or changing regulations and coordinates internal stakeholders to ensure development of strategies to address applicable changes
• 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
• 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
• Liaises with the Regulatory Operations team to coordinate publishing activities and timelines for assigned submissions
• Conducts regulatory research in relation to assigned programs and disseminates relevant information to management and cross-functional teams
• Performs other regulatory responsibilities/duties as assigned by the Senior Director, Regulatory Affairs

Candidate Profile:

• Considerable regulatory experience in a CRO/biotech/pharmaceutical company
• BSc degree in relevant/related discipline/industry required, advanced degree a plus
• Experience in CNS/psychiatric therapeutic area a plus
• 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
• Experience in interpretation of regulations, guidelines, policy statements, etc
• Experience and knowledge in the preparation of regulatory submissions, including amendments or supplements
• Strong attention to detail and the ability to manage multiple tasks
• Collaborative attitude and willingness to work in a cross-cultural environment
• Ability to work in a fast pace and dynamic atmosphere
• Adaptive thinking and “can-do” spirit
• Strong team player and communicator - proactive planner and solutions oriented
• Ability to work both independently with minimal supervision and within a matrix management structure
• Experience working with third party vendors, consultants and external partners