Senior Director, Global Regulatory Affairs

Remote

Company introduction:


COMPASS Pathways plc 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 a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). 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. COMPASS Pathways.


Location: Home-based in the United States or United Kingdom (can also be office based in New-York or London, UK).

 

Reports to: Vice-President, 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.


  • Responsible for directing global regulatory strategies for assigned projects and programs
  • Direct global clinical and pre-clinical regulatory strategies
  • Direct global life cycle management of products
  • Support development of the late stage clinical development plan
  • Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks
  • Provide regulatory guidance to company personnel throughout the research and development process
  • Set strategic direction and leads global regulatory submission process with submission teams, including marketing applications and core briefing packages
  • Develop and maintain the Core Data Sheet and lead global labeling team meetings
  • Advise on global CTA submission strategy
  • Direct the organization and preparation of clear and effective submissions
  • Prepare and deliver effective presentations for external and internal audience
  • Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.
  • Mentor Regulatory Managers and guide direct reports in carrying out responsibilities. Responsible for coordinating activities and career development of direct reports
  • Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position
  • Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development
  • Provide input to Regulatory Senior Management teams
  • Maintain a global view as part of the whole regulatory team


Profile:


  • 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 over-sighted 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


【For NYC】Compensation Description (annually):


The base salary range for this position in the selected city is $200,000 - $255,000 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 recognize employees for their work and any role at COMPASS, regardless of the location, is eligible for additional discretionary bonuses and equity.

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