Senior Manager, Regulatory Affairs
Content + Source + Freshness • 13 Dec 2025 • 95% confidence
Offer value
Moderate value due to essential role in regulatory affairs, but contract nature may deter long-term candidates and salary range is below industry averages.
- Engage in regulatory affairs for innovative mental health treatments
- Flexible hybrid working arrangement
- Contract role may limit long-term security
- Requires experience in regulatory processes
Pros
- Opportunity to engage in regulatory strategy for innovative therapies
- Hybrid/remote work structure allows for flexibility
- Essential role within a pioneering mental health organization
Cons
- Contract position may limit long-term security and benefits
- Salary range ($166,000–$215,000/year) lower than in some established firms
- Requires specific regulatory experience in a niche therapeutic area
Who it's for
Mid-Level • Hybrid / remote
Good fit
- Mid-level regulatory professionals
- Individuals interested in mental health advancements
- Team players looking to contribute to innovative projects
Not recommended for
- Entry-level candidates without experience
- Individuals seeking long-term permanent roles
- Those not aligned with mental health innovation
Motivation fit
Key skills
About the job
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, and has offices in New York City and San Francisco in the US. We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments.
We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways.
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
【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.
Benefits & Compensation:
For an overview of our benefits package and compensation information, please visit "Working at Compass".
Equal opportunities:
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.
Sponsorship:
Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.
Data Privacy:
All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.
