Regulatory Operations Specialist

MAPS PBC is seeking an enthusiastic, organized, and cognitively flexible team player to join the Regulatory Affairs Department as a Regulatory Operations Specialist (ROS).  

Reporting to the Regulatory Affairs Specialist, the ROS supports functions related to regulatory information management, submission management including document publishing in eCTD format for various regulatory application types in compliance with health agency regulations and guidelines, and other tasks as required. In addition to supporting submissions, the ROS participates in process improvement efforts across the Regulatory Affairs Department by implementing and maintaining systems for capturing key performance metrics. The individual in this position supports global regulatory programs, projects, and compliance initiatives across regions and business units.  

The ideal ROS has a strong technical background and is comfortable learning and navigating the online systems unique to various regulatory agencies, as well as other specialized technologies for research, clinical trials and project management.  The ROS must enjoy working within a small, entrepreneurial environment in which the ability to work under pressure and to handle a wide variety of activities is necessary.  Suitable candidates must be adept at organizing, managing, and communicating large amounts of information using document management systems, shared workspaces, and other digital tools.  

Location:  

This is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required. This position requires frequent phone and internet meetings. Certain home office expenses may be reimbursed. A work computer will be provided. Priority is placed on applicants based in the Pacific time zone (U.S. west coast). The MAPS PBC headquarters office is located in Santa Cruz, CA. Occasional travel may be required. 

Hours: Full time 40 hours per week.  We are a West Coast-based company and applicants must be available during normal business hours (9:00 AM - 6:00 PM Pacific Time, Monday through Friday). 

The exact schedule may be arranged upon hire. Occasional evening/weekend hours may be required. 

Position duties: 

• Support Regulatory Affairs in the planning, development, and publishing of submissions. 
• Collect, track, and organize submission components using various document management systems to ensure high-quality and timely final submissions. 
• Compile and submit electronic common technical document (eCTD) submissions to regulatory agencies.  
• Contribute to brainstorming and troubleshooting of technical issues that may impact validation requirements for submission as they arise.  
• Assist in drafting and review of regulatory documentation for clinical and nonclinical trials. 
• Track and work on multiple projects and protocols simultaneously and effectively. 
• Ensure tracking and archiving of regulatory documentation lifecycle: submissions, correspondence, and related information for various regulatory applications 
• Coordinate with the Safety team to facilitate submission of safety reports to agencies in alignment with current safety reporting standards. 
• Coordinate with the Data Science team to compile and/or QC study data output files and raw datasets into data tables for regulatory documents, utilizing a strong familiarity with or aptitude for software such as Excel. 
• Support updates and administration of regulatory submission systems as necessary. 
• Undertake assignments that may require some amount of problem-solving or lateral thinking to complete effectively. 

Minimum requirements: 

• A bachelor’s degree is required. A master’s degree is preferred. Preference for background in biological or data science (such as: Computer Science, Neuroscience, Cognitive Sciences, Data Science, or a similar field) with a strong interesting in clinical research. 
• 2-3 years of relevant experience in clinical trials, research methods, or statistical design and analysis. 
• The ability to understand requirements in whole and in detail and the ability to effectively perform analysis with problem-solving and lateral thinking. 
• Ability to quickly learn new computer technology software packages with minimal training, including technical problem-solving skills to investigate, debug, and effectively resolve issues  
• 1-2 years of experience with, and knowledge of, electronic common technical document (eCTD) submission processes, or demonstrable ability to quickly pick up and navigate regulatory electronic submission systems. 
• Proficiency with technologies used for reading, interpreting, and manipulating statistical output files or databases.  
• Strong aptitude for critical business software, including Microsoft Windows, Microsoft Office 365 Applications (Word, Outlook, etc.), OneDrive, and SharePoint.  
• Advanced proficiency with both Excel and Adobe Acrobat Professional. 
• Excellent written and verbal communication skills, especially in communicating technical information and specifications.  
• A willingness to stay abreast of new developments in the area of professional competence.  
• Possess 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 smartly prioritize tasks and take initiative.  
• The ability to work both independently and as part of a team. 
• High attention to detail. 

Additional Competencies:  

• Extensive knowledge of applicable clinical trial regulatory requirements in U.S. 
• Experience working for a clinical study Sponsor. 
• Experience interacting with the FDA, IRBs, or other regulatory agencies preferred. 
• Strong interpersonal skills that can be used to effectively collaborate on work with other technical personnel.  
• Demonstrates a result-oriented mindset, determination, ownership of responsibility, reliability, and accountability, while still working cohesively as a team member and following direction as part of a team under general supervision.  
• Recognize potential obstacles and work within set timelines.  
• Conscientious and precise delivery of work, especially when under pressure. 

General Responsibilities: 

• Communicate and collaborate with key players, internal, and external staff.  
• Check in regularly with manager and complete assignments by agreed deadline.  
• Follow SOPs and work instructions for regulatory and safety processes of MAPS PBC. 
• Document processes and provide regular updates. 
• Proactively seek methods of improvement for both individual work and project outcomes.   
• Proactively work to streamline work flows, troubleshoot and build efficiency 
• Participates in regular meetings at the project, department, and organizational level.  
• Manage project tasks in project management platforms such as Asana and Smartsheet.  

Compensation:  

This position is non-exempt from overtime. Salary available upon request.