European Regulatory Lead
Regulatory Affairs · Any City, Any State, California
About MAPS Public Benefit Corporation (MAPS PBC)
MAPS PBC catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics. We are currently focused on developing MDMA-assisted therapy as a Breakthrough Therapy for PTSD, with plans to submit for FDA approval in 2023. The results of our successful pivotal Phase 3 clinical trial were recently published in Nature Medicine and profiled on the front page of The New York Times.
Founded in 2014, MAPS PBC is a Public Benefit Corporation that prioritizes public benefit over profit. We are a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization working for over three decades to develop medical, legal, and cultural contexts for people to benefit from psychedelics.
Why work for MAPS Public Benefit Corporation (MAPS PBC)?
- We are a diverse team that shares a deep belief in the critical importance of our work and its potential to change the world.
- We are pioneering a new kind of pharmaceutical company that prioritizes public benefit and is committed to sustainability, accountability, and transparency.
- We are conducting high-quality scientific research at the cutting edge of psychiatry. We are committed to open science and regularly publish in leading scientific journals.
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.
European Regulatory Lead Executive Summary
Reporting to the Regulatory Affairs Manager, the European Regulatory Lead (ERL) plays an important role in the Regulatory Affairs Department supporting European clinical trials and correspondence with regulatory bodies in the European Economic Area and the United Kingdom. The ERL ensures comprehensive and cross-functional regulatory information management and strategically aligns requirements across various regulatory authorities in compliance with health agency regulations and guidelines. The right candidate will have a passion for clinical research in novel therapeutics and a proven track record of regulatory affairs experience.
- Serve as regulatory affairs expert for assigned clinical trials: perform all aspects of regulatory affairs including planning, development, and finalization of regulatory documents for multiple RA/EC/HTAs in Europe. Ensure high quality, timely, and consistent submission of regulatory documents.
- Collaborate cross-functionally on key aspects of clinical program: work alongside the Clinical Development Business Unit to contribute to program-specific documents, internal and external presentations, trainings, compliance, and process improvements as needed.
- Team leadership: mentor European study teams in overall regulatory strategy and compliance to enable future patient access expeditiously. Foster effective team communication and collaboration, providing honest and actionable feedback when relevant.
What you bring to the role:
- Advanced degree in a technical or scientific field with 2-3 years of direct experience in regulatory affairs in the pharmaceutical industry. Specific experience with UK or Germany preferred.
- Excellent communication skills, especially in communicating regulations, contingencies, and technical information.
- 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 based on general guidance
- Self-driven with strong time management and organizational skills, and the ability to prioritize tasks, and take initiative
- Experience working in the European Union and United States preferred.
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!