Regulatory And Compliance Lead

Summary

Join PicnicHealth as the Regulatory & Compliance Lead and spearhead efforts to ensure our decentralized trials and observational research meet the highest regulatory standards. You will develop and maintain a robust Quality Management System (QMS), shape regulatory strategies, oversee risk management, conduct audits, and validate our technology platform. This pivotal role requires extensive experience in clinical trial regulatory affairs and quality assurance, in-depth knowledge of global regulatory requirements, and proven ability to develop and implement effective regulatory strategies. You will guide our teams and partners through the evolving regulatory landscape, fostering innovative solutions aligned with our commitment to scientific excellence and patient-centered care. PicnicHealth offers a competitive compensation and benefits package, including a remote-first work environment, flexible time off, and comprehensive health benefits.

Requirements

• Extensive experience (8+ years) in clinical trial regulatory affairs and quality assurance, with a strong track record in helping build and evolve systems in a rapidly growing company
• In-depth knowledge of global regulatory requirements (GCP, ICH, 21CFR11, FDA guidance, etc.) and quality management principles (e.g., ICH Q9)
• Proven ability to develop and implement effective regulatory and quality strategies for decentralized trials and/or observational research
• Have led technology validation and compliance programs
• Excellent leadership and communication skills, with the ability to inspire, motivate, and build consensus across diverse teams
• A strategic, business-oriented thinker who can bring a keen understanding of risk management and mitigation strategies to weighing quality, regulatory, legal, and business risks
• A passion for innovation and a commitment to scientific excellence

Responsibilities

• Develop, enhance and maintain a robust Quality Management System (QMS) aligned with relevant regulatory requirements for the conduct of decentralized and observational research (FDA, GCP, ICH, etc.)
• Develop and implement a comprehensive strategy for navigating the evolving regulatory landscape for decentralized clinical trials, registries and observational research. Provide structure for how PicnicHealth approaches all regulatory activities for studies, including best practices for protocol development, safety reporting, informed consent, etc
• Develop and adopt a risk-based approach to monitoring clinical research studies
• Conduct regular audits and inspections of decentralized trial processes and technologies to identify and mitigate potential quality and compliance risks
• Oversee the validation of PicnicHealth’s technology platform and adherence to existing regulatory requirements (21CFR11, etc.)
• Stay abreast of emerging trends and best practices in decentralized trial regulations and quality management. Be a resource for our internal teams and our customers for how we approach regulatory and quality consistent with existing and new expectations and requirements
• Use your deep understanding of regulatory requirements combined with experience at a fast moving small company to help identify risks, know when to innovate, work collaboratively with diverse stakeholders, and drive to innovative, fit-for-purpose solutions

Preferred Qualifications

Have experience working in a start-up environment with a focus on both technical and scientific excellence and an entrepreneurial spirit and are seeking a high-growth, fast-paced environment where you can innovate and help build a disruptive business

Benefits

• Comprehensive benefits including above market Health, Dental, Vision
• Family friendly environment
• Flexible time off
• 401k plan
• Free PicnicHealth account
• Equipment and internet funds for home office set up
• Wellness Stipend
• Remote first company, with teammates spread across the US. We support in-person gatherings, including co-working spaces and multi-day onsites,  to build connections and move forward strategic initiatives. Expect to travel 2-4 times a year.  For our team members in the Bay Area, who prefer to work in person we can offer a hybrid set up to work from the SF office on a flexible schedule