Company Profile

Rakuten Aspyrian, Inc., is a privately funded clinical stage biotechnology company with offices in the USA, Japan and Germany. Since 2013, Rakuten Aspyrian has been developing new anticancer therapies based on the Photoimmunotherapy platform. Rakuten Aspyrian plans to become a fully integrated biopharma with research, development, and world-wide commercialization of therapies based on the Photoimmunotherapy platform.

Our long-term objective is to commercialize a number of therapies based on Photoimmunotherapy to treat a broad range of solid tumor types as single agent and in combination with other immunomodulatory agents to generate robust and long lasting anticancer immunological responses.

Rakuten Aspyrian is currently sponsoring a global Phase 3 multicenter clinical study for ASP-1929 to evaluate the efficacy and safety of ASP-1929 in patients with recurrent Head and Neck Cancer and additional Phase 2 studies to evaluate the safety and efficacy of ASP-1929 in patients with other cancer types.

Given the rapid progression of the clinical studies we are quickly expanding the team to support late stage pivotal clinical development and future commercialization of our products.

Position Summary

The Director of Regulatory Affairs will be responsible for working with Rakuten Aspyrian development teams to implement global regulatory affairs strategy for assigned company projects with the goal of ensuring timely clinical study execution, CMC development, and BLA readiness for our biologic/drug combination therapies. Responsibilities will span pre-IND through post-approval phases of development. This individual will interact with regulatory health authorities in all countries where Rakuten Aspyrian conducts clinical studies and/or intends to market a product. The Regulatory Affairs Director will work closely with other functions of the company, including quality assurance, clinical affairs, clinical development, pharmacovigilance, medical affairs, CMC, regulatory operations, and project management.

Key Duties and Responsibilities

  • Ensure that corporate policies and clinical programs are aligned with rules and regulations governing the global development of pharmaceuticals
  • Develop and implement strategies for the earliest possible approval of regulatory applications
  • Advise and manage regulatory consultants
  • Oversee ongoing projects from a Regulatory perspective.
  • Participate in product strategy teams to provide advice and direction, including identifying and assessing regulatory risks regarding global regulatory requirements and strategies
  • Work closely with development teams to write, review, and revise documents for submission to regulatory health authorities (US, EU, Asia, Canada) to ensure:
    • Appropriate planning, review, and tracking of all regulatory submission documents
    • Acceptability of data, procedures, and other documentation presented in support of clinical trials through submission of marketing application(s)
    • Regulatory arguments are presented clearly and conclusions are supported by data and their associated risk assessments
    • Appropriate reporting of safety
    • Document publishing, QC, and submission occurs in a timely fashion
  • Interact and communicate with regulatory health authorities in countries where Rakuten Aspyrian is conducting clinical trials or plans to market product
  • Perform regulatory intelligence activities to keep current on the global regulatory environment and competitive products; communicate such environment to the teams
  • Participate in the development of Regulatory Affairs department SOPs
  • Work with regulatory and quality teams to ensure compliance with the global regulatory health authority regulations and interpretations and to design and implement training on regulatory issues for staff and for business stakeholders
  • Other duties as assigned

Desired Education, Skills and Experience

  • Bachelor’s and Master’s or Ph.D. degree in scientific, health care, or related field or equivalent.
  • A minimum of 7 years of pharmaceutical industry experience
  • 5+ years of regulatory experience
  • Experience in a strategic leadership capacity
  • Must demonstrate understanding of drug development and knowledge of FDA requirements
  • Direct experience with FDA required and international experience preferred
  • Device and/or combination product experience preferred
  • Highly organized with attention to detail.
  • Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills
  • Working knowledge of electronic publishing/file management system.
  • Familiarity with MS Word, MS Excel, Adobe Acrobat and PowerPoint applications.
  • Exceptional self-management ability
  • Travel as needed for interactions with Regulatory Health Authorities

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Rakuten Aspyrian Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.

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