The Director, Global Regulatory Affairs, Regulatory Program Management will be responsible for driving GRA operational activities for product development programs that result in successful execution and implementation of Regulatory strategies, coordinates timelines and milestones for timely delivery of Regulatory output across COMPANY departments and in conjunction with concurrent activities within and across COMPANY relevant sectors. This role interfaces and monitors all streams of product programs and any subsequently USA-approved product deliverables, activities, and/or obligations leading to FDA engagements (or engagements with ROW Authorities when required/requested).
Additionally, this role organizes and implements Regulatory strategies for additional investigational products (e.g., in the COMPANY pipeline) awaiting Regulatory submission/FDA actions that need to be addressed/moved on/maintained from a Regulatory compliance standpoint. This role includes similar coverage for post-approval products or any product brought into the COMPANY portfolio.
COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving 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 therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support.
COMP360 has been designated a Breakthrough Therapy by 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). We have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running phase II clinical trials of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com
Location: Home-based in the United States or United Kingdom (can also be office based in New-York or London, UK).
Reports to: The Director, Global Regulatory Affairs, Regulatory Program Management will report to SVP, Global Regulatory Affairs.
Roles and responsibilities:
This Regulatory-focused project/franchise program oversight and solutions-focused position requires the employee to have extensive hands-on involvement, people skills, communication sensitivity, and contemporary cross-cultural global work experience. This position interfaces with all disciplines within product development that include (i.e., but are not limited to) CMC, Clinical, Medical Writing, PV, Quality, specialty contractors and consultancies as well as EU Project Management and Clinical/Medical Affairs contributors; represents COMPANY Regulatory to external partners, vendors, consultants, contractors, and stakeholders in a leadership role.
This position requires the candidate to demonstrate foresight and analytic skills; be independent, action-oriented, an excellent communicator and work well within international project teams to ensure all Regulatory strategic events, interactions, and corporate submission timelines are met.
- Guides/informs domestic/international colleagues, Senior Management and dossier managers handling multiple deadlines, about pending arrangements, preparations and submissions of domestic/international registration dossiers for COMPANY products such that work is initiated and completed in a manner and outcome that is aligned with a company-wide prioritization of projects
- Utilizes advanced career experience to mentor, lead, and oversee junior COMPANY Regulatory colleagues with carrying out preparations for interactions with domestic and international Agency personnel (at peer levels) to achieve corporate goals and objectives
- Provides COMPANY Executive Leadership and partners/stakeholders (as appropriate) with active timeline visibility/monitoring, assessments of critical path risks and conflicts, mitigation strategies and informs/alerts Management of activities that impact COMPANYs immediate, short and long-term Regulatory and commercial goals/objections
- Lay out timelines/milestones for activities that result in completion of submission of INDs, NDAs and amendments for domestically generated investigational products and international COMPANY products when needed
- Strategize, coordinate competing priorities as illuminated by timelines for preparation and submission of dossiers, serial submissions, annual reports, Variations, and Orphan Designation/Pediatrics/Breakthrough (or similar) for consideration by Regulators
- Develop, document and implement short- and long-term Regulatory timelines/milestones for key projects ensuring all timelines are detailed; dig down to specifics and clearly identify task owners for all submissions activities and compliance duties
- Primary responsibility for translating the work described in duties 1-3 into resulting budget and resource projections, contractual arrangements, SOW consultancies and integrated fiduciary-related timelines/planning/accounts such that financial project plans are successfully submitted on time and stay within budget
- Works cooperatively with Finance, Accounting, Billing departments and cross functional PMs from other disciplines to accurately estimate and represent project costs and mitigation plans to address changes to programs should they occur
- Use leadership skills to supply timely and clear communications, notifications, and updates to Company Senior and Executive Leadership
- Ensure that cross-functional resources are assigned, aligned, realistic, and held accountable for task completion and delivering outcomes for Regulatory deliverables
- Guide and partners with non-Regulatory collaborators (e.g., Nonclinical, CMC, and Clin/Med personnel) through managing/prioritizing competing IND, CTA and NDA commitments and competing resource management during periods of shortened resources and/or timing
- Generate gap analyses of pre-existing work/data/files being considered for registration of products in the USA
- Develop solutions and works with Regulatory staff/SMEs to resolve technical issues and deficiency
- Provide Regulatory project management and tactical guidance for development teams handling Regulatory and clinical work including pre-market, post-market environments
- Support Regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed
- Ensure team deliverables are in compliant with the quality system process and standard product development process, and meet the business expectations
- Build broad professional network across functions, throughout COMPANY, and with external industry parties or business partners
- Effectively communicate project plans, status and resource requirements to both core teams and senior management
- Provides strategic prioritization and mentoring to other Regulatory Specialists and others in the organization; actively involved with management in setting broad organizational strategies
- Responsible for achieving, in a timely manner, successful implementation of governmental regulations while ensuring best-in-class practices as a competitive advantage for the business
- Oversees the delivery of electronic data submitted to health authorities through up-to-date, accurately registered gateways or portals
- Create “can-do” attitude and work style within project teams to guide and advise the teams with regard to most efficient Regulatory approaches to development and approval pathways
- In conjunction with teammates, communicate with industry agencies (national and, when appropriate, international) as needed at a peer-to-peer level to resolve Regulatory delays or misunderstandings and expedite approvals of products
- Guide and implement timing for strategies from Management to address inquiries from domestic and international Regulatory authorities and handle meetings arrangements with regulators as necessary
- Directs day-to-day activities for multiple project teams through managing project plans, resourcing, status reporting, resolving issues, and uses anticipatory guidance to identify project risks and accountability gaps for RA deliverables across multiple internal and external parties
- Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost
- Research, assess and coordinate initiation of third party resourcing at request of SVP/CR&DO for situations requiring contractors, vendors, stakeholders, suppliers, experts, etc. specialization or alternative solutions
- Lead department staff in time management and organization/implementation of review cycles for the preparation of Regulatory responses and all other applications and routine reports/renewals, including the preparation and submission of supplements and amendments as required by internal departments (Manufacturing, QA/QC, Medical, etc.) to update investigational and commercial dossiers and labeling
- Directs and oversees day-to-day activities that track progress of multiple teams through managing project plans, resourcing, status-reporting, resolving issues, identifying project risks and accountability for deliverables across multiple functional organizations
- Establishes meaningful metrics and KPIs
- Perform other duties as assigned
- Advanced health, science, or human service degree required along with significant industry experience preparing unique documents for, or interactions with, regulators and business stakeholders (partners, investors, etc.) as well as INDs and NDAs. Must have been directly involved in handling the operational tasks surrounding preparations for intense and well-prepared engagement with U.S. (emphasis) and international health authorities
- Extensive experience in the pharmaceutical industry and a working understanding of the U.S. Regulatory environment and global impact of product development strategies
- Must have project managed/program oversighted at least two original BLAs/NDAs that were accepted for filing
- Must have handled all budget, contractual, consultancy, and fiduciary-related timelines/planning/accounts for at least two original BLAs/NDAs that were successfully submitted on time and within budget
- Must have a history of working cooperatively with finance, accounting, and billing departments and cross-functional PMs from other disciplines
- Team and goal oriented mindset to interact with the various functional groups
- Significant experience is required in the organizing of all contributors and materials including but not limited to, CMC, Nonclinical and Clinical sections of INDs and BLAs/NDAs and other significant submission packages
- Good computer skills and willingness to roll-up the sleeves is essential
- Strong project management skills/experience required
- Prior experience/facility with Microsoft Project®, Smartsheet®, Monday®, and/or similar project management platforms required
- Intuitive, people-oriented communication skills and work style in managing work completion in a cross-cultural collaborative environment
- Defines resources & objectives required to meet corporate goals
- Scope: Participates with other senior managers to establish strategic plans and objectives. Makes final decisions on administrative or operational matters and ensures achievement of objectives
- Complexity: Develops methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements
- Impact: Erroneous decisions will have a serious impact on the overall success of function, division, or company operations
- Interaction: Interacts with executives internally and externally. Interactions involve skills such as negotiating with or influencing senior level leaders regarding matters of significance to the organization. Influences policymaking
- Supervision: Directs activities of a functional area. Controls planning, project budget projections, managing expense priorities and oversees vendor scope and performance. Recommends and implements changes to methods. Provides coaching, mentoring and performance feedback to employees