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 Regulatory Affairs Manager will report to the Director of Regulatory Affairs and will be responsible for supporting the development and implementation of regulatory strategies with a goal to ensuring timely clinical study starts and execution, CMC development, and BLA readiness for Aspyrian’s biologic/drug combination therapies. The Regulatory Manager will work closely with other functions of the company, including Quality Assurance, Clinical Affairs, Supply Chain, CMC, and Program Management.

The ideal candidate will have good understanding of GCP, GMP, and GLP and be able to advise teams regarding these and other country-specific health authority regulations. The candidate should have experience with filing INDs and CTAs and with coordinating and responding to health authority questions related to those filings. The candidate should have sufficient drug development experience to advise teams regarding development activities and documentation needed for a successful marketing application.

Strong organizational and writing/reviewing skills, excellent interpersonal/teamwork skills, and an ability to be flexible and work in a fast-paced environment with tight timelines are required.

Key Duties and Responsibilities

Regulatory Affairs Manager will be responsible for:

• Assisting with strategy development for global regulatory filings (INDs, CTAs, CTNs, BLAs)
• Compiling list of data required, submission content, and templates for regulatory filings
• Working with Subject Matter Experts to compile data and content for regulatory filings and ensuring that regulatory documents are written per timelines
• Reviewing regulatory filings to ensure data is appropriate, scientifically sound, and presented in a clear and concise fashion
• Working with contractors to ensure regulatory submissions are formatted, published, and filed in a timely fashion
• Tracking filing submission dates, questions from Regulatory Health Authorities, responses, and approval dates
• Working with Quality to ensure country-specific requirements and regulations are managed and tracked
• Tracking new quality, CMC, nonclinical, and clinical regulations and guidances and disseminating knowledge to colleagues
• Work with SMEs to ensure delivery of high quality documentation to meet global regulatory expectations with proper storage and retrieval capabilities

• Other duties as assigned

Desired Education, Skills and Experience

• Minimum of 3-5 years of regulatory experience or equivalent combination of pharmaceutical development and regulatory affairs experience
• B.S./M.S. or higher degree in a life or physical science
• RAC accreditation is desirable
• Extensive knowledge of FDA/EMA biologic development requirements, regulations, guidances
• Excellent organizational skills, ability to work collaboratively in a team environment, and ability to meet deadlines
• Excellent knowledge of GMP, GCP, GLP and FDA, EMA, and ICH regulations and guidance documents
• Knowledge of device guidance and IDE, 510(k) and PMA requirements desirable
• Ability to operate independently and proactively

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.