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 and 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.
Director of Regulatory Affairs Executive Summary
The Director of Regulatory Affairs is an enthusiastic, strategic and organized leader who is responsible for carrying forward and executing regulatory strategy in accordance with the company mission and objectives. Reporting to the Chief Scientific Officer, this role manages the Regulatory Affairs Department. The Director serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of investigational therapies, and provides regulatory strategic oversight to help ensure regulatory compliance of promotional materials.
Key Responsibilities
- Serve as regulatory affairs expert: Responsible for directing global regulatory strategies and global life cycle management of products. Manage interactions and relationships with FDA and other regulatory authorities acting as primary contact for Regulatory Authorities. Contribute to the preparation of regulatory submissions that are technically complex and cross-functional including IND, NDA, MAA submissions, clinical trial applications, core data sheets, and reports.
- Lead regulatory strategy: Ensure that regulatory requirements are integrated in product and disease-state communications. Identify, assess, and mitigate regulatory risks associated with product development. Manage all external and internal partnerships relating to regulatory strategy, including vendors and consultants that are fulfilling regulatory functions.
- Team leadership: 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 with internal stakeholders, providing honest and actionable feedback when relevant.
Minimum Requirements
- Degree in life sciences or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) in biological or healthcare scientific discipline preferred.
- 12+ years of relevant experience
- 5+ years' experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years' experience specific to Regulatory Affairs – Advertising and Promotion. Candidates with experience in related fields may also be considered.
- Experience in pharmaceutical/biologics regulatory, or scientific disciplines
- 2+ years of experience as the primary Regulatory representative in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents Experience and training in ICH-GCP. Guidelines and other applicable regulatory requirements.
- Medical Legal Regulatory review and Commercial Regulatory experience required.
- Experience with REMS programs and CMC Regulatory requirements.
- Thorough knowledge of applicable Health Authority codes, laws, regulations, guidance, and industry standards for compliant advertising/promotion and scientific exchange of prescription drug products, including during the investigational and post-approval phases.
- Proficiency in Microsoft Office365, Adobe Acrobat Professional and project management applications.
- Confident and influential approach
- Experience managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
- Familiarity with Veeva, PromoMats, and Veeva MedComms preferred
- Excellent understanding of US regulations for drug promotion/advertising and experience in the regulatory review of prescription drug advertising and promotion including product launches
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!