Position: Head of Global Regulatory Affairs MAPS PBC California Full-time

About MAPS Public Benefit Corporation (MAPS PBC)

MAPS PBC is pioneering a new form of mental health care, beginning with the development of MDMA-assisted therapy as an FDA-approved treatment for PTSD. MDMA-assisted therapy is a new paradigm in the treatment of mental health, combining a medicine with psychotherapy to address the root causes of PTSD. It has been designated a Breakthrough Therapy by the FDA and the results of our pivotal Phase 3 clinical trial were published in Nature Medicine or profiled on the front page of The New York Times.

MAPS PBC is a Public Benefit Corporation, with a dual mandate to generate shareholder value and public benefit. We are a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit working for over three decades to develop medical, legal, and cultural contexts for people to benefit from psychedelics. We are committed to continuing to lead the field of psychedelic medicine with integrity and ethics at the core.

Why work for MAPS Public Benefit Corporation (MAPS PBC)?

• We are a diverse team that shares a deep belief in the critical need for innovation and expanded access in the treatment of mental health conditions.
• We are entrepreneurial, collaborative, and open-minded in how we approach our innovative work.
• We are a new kind of pharmaceutical company that prioritizes public benefit over profit and is committed to sustainability, accountability, and transparency.

We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, military and veteran status, religions, abilities, and perspectives. MAPS PBC values and seeks applicants who are people of color, queer, transgender, gender non-conforming, and gender fluid people. MAPS PBC strives to establish a supportive, equitable and accessible work environment.

Global Head of Regulatory Affairs Executive Summary

Reporting to the Chief Scientific Officer, the Global Head of Regulatory Affairs leads the Regulatory Affairs Department in developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with global business strategy. The incumbent is responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, UK/EEA, JP, and China). The right candidate will have a passion for clinical research in novel therapeutics to address unmet medical need and a proven track record of success in regulatory affairs.

Key Responsibilities

• Serve as regulatory affairs expert for clinical trials: Responsible for directing global clinical and pre-clinical regulatory strategies and global life cycle management of products. Develop and maintain the Core Data Sheet and lead global labeling team meetings.
• Collaborate cross-functionally on key aspects of clinical program: Identify, assess, and mitigate regulatory risks associated with product development. Provide regulatory guidance to company personnel throughout the research and development process.
• Team leadership: Set strategic direction and lead global regulatory submission process with submission teams, including marketing applications and core briefing packages to enable patient access expeditiously. Foster effective team communication and collaboration, providing honest and actionable feedback when relevant.

Position Requirements

What you bring to the role:

• Advanced degree in a technical or scientific field
• 15+ years of pharmaceutical/biotechnology industry experience with technical management, 6 years of direct strategic experience in regulatory affairs in industry
• Extensive regulatory experience working on products in late stage development, preferably including leading a significant submission (eg NDA or BLA, MAA). Prior experience as a regional regulatory lead, ideally US and/or UK/EU in pharmaceutical industry
• Expert knowledge with respect to the respective regulatory landscapes in the US, UK/EEA, Canada, Australia, and Japan
• Direct experience in interfacing with relevant regulatory authorities (FDA, EMA, and PMDA).
• Excellent communication skills, especially in communicating regulations, contingencies, and technical information.
• Ability to foster effective, positive interactions with regulatory agencies, and corporate partners
• Ability to lead and influence project teams, committees, etc. to attain group goals
• Strong aptitude for learning critical business software
• Advanced proficiency with both Excel and Adobe Acrobat Professional preferred
• Sound judgment, discretion, and strong critical thinking skills to make informed decisions
• Self-driven with strong time management and organizational skills
• Supervisory/mentoring experience, including ability to guide, train, supervise and prioritize workload of direct reports in highly technical field
• Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff
• Strong sensitivity for a multicultural/multinational environment, and demonstrated experience leading multi-disciplinary teams
• Experience in interpretation of regulations, guidelines, policy statements
• Cover letter required; incomplete applications may not be considered.

MAPS PBC is a distributed team that uses technology and periodic in-person gatherings to stay connected. We look for people who are comfortable with and skilled at remote work and collaboration

Competitive benefit package includes:

• Paid Time Off (PTO)
• Sick Time
• Holiday Pay
• Employer paid medical, dental, vision, and life insurance (100% covered for employees + 50% for dependents)
• Employer funded mental health HRA
• Employer funded SEP IRA
• FSA/Dep Care
• Pet Insurance
• Home Office Stipend
• Wellness Wednesday/Journal Club/Yoga/Meditation and so much more!

MAPS PBC commits to building a supportive, equitable, and accessible workplace. We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, arrest or conviction record, military and veteran status, religions, abilities, and perspectives.