Regulatory Affairs and Submission Specialist (RASS)

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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. 

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 establish a supportive, equitable and accessible work environment.

Call for Candidates

MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Research Development and Regulatory Affairs department. The RASS will oversee regulatory submission processes involving eCTD, non-eCTD electronic-only submissions, and administrative processes (e.g. filing, corresponding tracking, etc.). Frequent drafting and review of regulatory submission documents (protocols, meeting requests, etc.) will be done as necessary. The RASS 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 the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, and organizational skills, and the ability to maintain a realistic balance among multiple priorities. 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. Interested and qualified candidates are encouraged to apply online at: tinyurl.com/applyMPBC

 

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. Applicants must be available 40 hours a week, during normal business hours (9:00 AM – 6:00 PM Monday-Friday PST). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.

 

Compensation

This position is exempt from overtime.

 

Position Duties

  • Coordinate electronic common technical document (eCTD) submissions to regulatory agencies (FDA, EMA, Health Canada)
  • Operate regulatory submission systems including, but not limited to, ARIM, WebTrader, Eudralink, and EudraCT
  • Manage the tracking and storage of regulatory documentation, submissions, and communications.
  • Compile regulatory documentation data tables from study data output files (SAS & SPSS) and raw datasets (Excel)
  • Assist in drafting and review/revision of key regulatory documentation for clinical and nonclinical trials including Clinical Study Reports, FDA responses, specific protocol sections.
  • QC statistical output files (SAS & SPSS) and raw data sets (Excel) for inclusion in regulatory documentation data tables
  • Regularly perform medical coding of diagnoses and medications (MedDRA & WHODrug)
  • Assist in drafting and review of Clinical Study Reports
  • Update current safety reporting standards and facilitate submission of safety reports to agencies
  • Develop SOPs and work instructions for current medical coding, regulatory, and safety standards
  • Manage updates and administration of regulatory submission systems as necessary
  • Reports to the Director of Research Development and Regulatory Affairs weekly and participate in regular meetings on the project, department, and organizational level.
  • Manage project tasks on Asana and contribute to project management.

Minimum Requirements

A bachelor’s degree is required in Computer Science, Neuroscience, Cognitive Psychology/Science, Data Science, or a similar field. A master’s degree is preferred.

  • 2 years of experience and knowledge of electronic common technical document (eCTD) submission processes required
  • 1-2 yearsof relevant experience in big-data methods, research methods, or statistical design and analysis required
  • 1-2 years of relevant experience in clinical regulatory writing preferred
  • Technical proficiency in reading statistical programming output files (e.g. SPSS, R, SAS, etc.).
  • A willingness to stay abreast of the development in the area of professional competence.
  • The effective ability to understand requirements in whole and in detail and the ability to perform strong analysis and technical problem-solving skills to investigate, debug, and effectively report issues.

Strong working knowledge of Microsoft Office 365 Applications (Word, Excel, Outlook, etc.)

 

Additional Competencies

    • Self-driven with the ability to work independently and within a team.
    • Open and clear communicator.
    • Excellent written and verbal communication skills, especially in communicating business and technical information and statistical information and specifications.
    • Capable of preparing and delivering requirements.
    • Strong interpersonal skills that can be used to effectively collaborate on work with other professionals.
    • Ability to present to small groups.
    • 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

    Be 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. 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.

To apply, visit https://tinyurl.com/applyMPBC.

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Santa Cruz, CA 95060-9989

MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a 501(c)(3) non-profit research and educational organization.