200 Inner Belt Road
Regulatory Affairs Associate / Senior Regulatory Affairs Associate at OpenBiome
OpenBiome is a nonprofit stool bank, expanding clinical access to fecal transplants and catalyzing research on the human microbiome. Fecal microbiota transplantation (FMT) is a promising new therapy for C. difficile, the most common hospital-acquired infection in the country. OpenBiome provides microbiota preparations to clinicians performing FMT, and supports clinical trials and basic research investigating new applications of microbiome-based therapies.
Five years ago, OpenBiome started the first public stool banking service, and we have grown to redefine the standard of care for this emerging field. Today, we support FMT programs at over 1000 medical centers across all 50 states and 7 countries, and have delivered over 30,000 treatments for recurrent C. difficile patients. We have also developed a new oral formulation for delivering FMT, published dozens of scholarly works and have supported over 30 clinical studies to identify new applications for FMT. As the leader in this exciting new field, OpenBiome is uniquely positioned to continue to expand access to care and discover new applications for microbial interventions. We are searching for passionate teammates eager to support this mission.
Regulatory Affairs Associate Job Description
We are looking for a full-time Regulatory Affairs Associate / Sr. Regulatory Affairs Associate to drive compliance with our regulatory obligations across our organization. The ideal candidate has strong writing skills and is self-motivated, mission-driven, a quick learner, and detail-oriented. This is a full time, exempt position with comprehensive benefits package.
Duties & Responsibilities:
- Collaborate with Clinical Research team to assure timely and thorough preparation and submission of required regulatory submissions for OpenBiome-sponsored and investigator-sponsored clinical trials, including Single-Patient IND submissions
- Conduct regulatory research and interpret regulatory guidance as needed to support international clinical trials for Global Microbiome Health Initiative
- Survey the regulatory landscape and help the Clinical Research team implement regulatory guidance in advance of changes
- Communicate with FDA regarding OpenBiome’s Biologics Master File portfolio and
- Liaison with counterpart at Finch Therapeutics Group, OpenBiome’s licensed manufacturer of FMT products
- Participate in clinical research and regulatory systems audits for compliance
- Provide administrative support for corporate compliance program
- Train new hires on the topic of sponsor responsibilities in conducting clinical trials
- The Regulatory Affairs Associate is ideal for candidates with a BA/BS degree and 2-3 years of experience in clinical research, regulatory affairs, or a related field regulated by the FDA
- The Sr. Regulatory Affairs Associate is ideal for candidates with a BA/BS degree or higher and 4-6 years of experience in clinical research, regulatory affairs, or a related field regulated by the FDA
- Very strong writing and editing skills
- General knowledge of drug development and clinical trials
- Proficiency in regulatory (FDA, ICH, GCP, and GMP) guidelines
- Experience in setting up and maintaining a Trial Master File
- Ability to multi-task and manage multiple deadlines simultaneously
- Highly detail-oriented and organized
- Open to receiving both formal and informal feedback
- Passion, humility, and excitement for doing whatever it takes to meet a great public health need
- Must be legally eligible for work in the United States
OpenBiome is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or verteran status
Minimum Education Required
How To Apply
How to Apply
To apply, please go to www.openbiome.org/jobs and submit your Cover Letter and Resume. The start date for this position is flexible.