Regulatory Operations Specialist (ROS) - Remote Position

Research Development and Regulatory Affairs · Santa Cruz, California
Department Research Development and Regulatory Affairs
Employment Type Full-Time
Minimum Experience Entry-level

About MAPS Public Benefit Corporation (MAPS PBC):


MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. 


 More information about the organization is available at http://www.mapspublicbenefit.com


MAPS PBC is committed to the evolution of psychedelic healing modalities. We are building a diverse and inclusive workplace where we learn from each other.  We value transparency, autonomy, experimentation, and kind, direct feedback. We welcome applicants who thrive in the midst of a growing organization that values science and healing. 


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 continually improve upon the supportive, equitable and accessible work environment.  


Call for Candidates:


MAPS PBC is seeking a dedicated team player who is focused and organized to join the Regulatory Affairs Department as our new Regulatory Operations Specialist (ROS). The ROS will support various functions related to document publishing in eCTD format, regulatory information management, and submission management among other tasks as required. Under the direction of the Senior Director, Head of Research Development & Regulatory Affairs, with day to day reporting to the Regulatory Affairs Specialist, the ROS supports various regulatory application types in compliance with health agency regulations and guidelines. The ROS will participate in process improvement efforts across the Regulatory Affairs Department, supporting submissions, developing, implementing and maintaining systems to capture key performance metrics. The individual in this position will support global regulatory programs and projects and compliance initiatives across regions and business units. The ROS must be creative and enjoy working within a small, entrepreneurial environment that is mission-driven, results-driven, and research-oriented. The ideal individual will have strong technical capabilities to work within quality systems. The ability to work under pressure to handle a wide variety of activities is also necessary.  Suitable candidates are able to work well in a fast environment and are adept at organizing and managing lots of information virtually. 


 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 with a satellite office in Oakland, CA. Occasional travel may be required.


Hours:  Full time 40 hours per week. Applicants must be available during normal business hours for a California-based company. The exact schedule may be arranged upon hire. Occasional evening/weekend hours may be required.


Position duties:


  • Electronic document organization and submission of electronic common technical document (eCTD) submissions to regulatory agencies.
  • Organize receipt of submission components and workflow completion to ensure a high-quality and timely final submission.
  • Contribute to brainstorming and troubleshooting of technical issues that impact validation requirements for submission. 
  • Support Regulatory Affairs in the planning, development, and publishing of submissions.
  • Support the tracking and storage of regulatory documentation, submissions, and communications.
  • Ensure tracking and archiving of regulatory filings, correspondence and related information for various regulatory applications
  • Participates in the evaluation, selection and implementation of technology and equipment related to regulatory submissions assembly and/or archiving
  • Compile regulatory documentation data tables from study data output files and raw datasets.
  • Assist in drafting and review regulatory documentation for clinical and nonclinical trials.
  • QC statistical output files and raw data sets for inclusion in regulatory submission data tables.
  • Facilitate submission of safety reports to agencies in alignment with current safety reporting standards.
  • Manage updates and administration of regulatory submission systems as necessary.


Minimum requirements:


  • A bachelor’s degree is required. A master’s degree is preferred. Preference for background in biological or data science (such as: in Computer Science, Neuroscience, Cognitive Sciences, Data Science, or a similar field). 
  • 1-2 years of experience and knowledge of electronic common technical document (eCTD) submission processes preferred.
  • 1-2 years of relevant experience in big-data methods, research methods, or statistical design and analysis preferred.
  • Ability to quickly learn new computer technology software packages with minimal training.
  • Analytical and problem-solving skills associated with software and complex documents, including the ability to detect, troubleshoot and rectify routine issues with systems.
  • Technical proficiency in reading statistical output files. A willingness to stay abreast of the development in the area of professional competence.
  • Strong proficiency of Windows, Microsoft Office 365 Applications (Word, Excel, Outlook, etc.), OneDrive, Sharepoint.
  • Advance use of Adobe Acrobat or other Adobe plug-in publishing tools.


Additional Competencies:


  • Self-driven with the ability to work independently and within a team.
  • High attention to detail.
  • Excellent written and verbal communication skills, especially in communicating technical information and specifications.
  • Strong interpersonal skills that can be used to effectively collaborate on work with other technical personnel.
  • Demonstrates a results-orientation, determination, ownership of responsibility, reliability, and accountability, and yet functions as a team member and follows direction as part of a team under general supervision.
  • Coordination and planning of tasks and time management. 
  • Recognize potential obstacles and work within set timelines. 
  • Conscientious and precise delivery of work even when under pressure. 
  • Proactive in problem solving. 


General Responsibilities:


  • Communicate and collaborate with key players, internal and external staff.
  • Check in regularly with Department Director and complete assignments by agreed deadline.
  • Follow SOPs and work instructions for regulatory and safety processes of MAPS PBC 
  • Document process and provide regular updates.
  • Proactively seek methods of improvement, of individual work and project outcomes. 
  • Proactively work to streamline work flows, build efficiency, security and user interface of various platforms.
  • Participates in regular meetings on 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. 

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  • Location
    Santa Cruz, California
  • Department
    Research Development and Regulatory Affairs
  • Employment Type
    Full-Time
  • Minimum Experience
    Entry-level