Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.
Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.
Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 6 locations in 6 countries: the United States, Japan, Taiwan, The Netherlands, Switzerland and India. For more information, visit www.rakuten-med.com.
The Regulatory Affairs head will be a key leader of our management team and will provide management and leadership of the Regulatory Affairs to support the development and implementation of regulatory strategies and processes to secure worldwide product approvals.
The Regulatory Affairs head will work directly with Rakuten Medical’s functional leaders and external consultants and will lead the integration of Regulatory Affairs across all the operative functions related with clinical development, CMC, devices, quality assurance and future product commercial launch initiatives.
Desired areas of expertise include the following: (i) clinical trial design including trial design for accelerated approvals, (ii) pharmacovigilance and drug safety compliance, (iii) regulatory submissions and discussions with the FDA, EMA and PMDA, (iv) CMC/cGMP of biologics to support pivotal studies and commercial launch, (v) device regulatory compliance for world-wide use, (vi) requests for orphan designation, breakthrough designation, fast track, accelerated approval, (vii) commercial launch and product promotional activities.
Understanding of Quality Assurance and Quality Management Systems will be valued and potentially the Regulatory Affairs head will be considered to oversee the Quality Assurance organization.
We are looking for a hands-on candidate with strong leadership kills, a candidate that thrives in a fast-paced, highly interactive, and non-bureaucratic start-up environment, a candidate with excellent interpersonal skills that is determined to execute under tight timelines, a candidate that is energized by our mission to provide the patients with transformative treatments so they can conquer their disease.
The Regulatory Affairs position will be based in Rakuten Medical’s San Diego corporate office, however, we may consider the flexibility to work remotely as long as the candidate can visit frequently the San Diego corporate office. The Regulatory Affairs head will report directly to the COO.
Key Duties and Responsibilities
- Provide management and leadership of the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide
- Serve as point of contact and represent the Company before regulatory authorities, including preparation of meeting agendas, materials, and minutes
- Execute US /OUS regulatory project plans in collaboration with Rakuten Medical management, clinical, CMC and device groups as well as regulatory consultants, and CROs
- Manage and oversee of all operational aspects of regulatory submissions, including maintaining timelines and developing and coordinating submission content for various regulatory FDA, EMA and PDMA applications, safety, amendments, and IND safety and annual reports
- Have and maintain awareness of existing and new regulations and guidance for quality, CMC, nonclinical and clinical matters, devices and advise on expectations and requirements for US and OUS compliance
- Oversee Quality Management Operations
- Provide counsel, training, and interpretation of FDA and other regulatory agencies to Company personnel
- Contribute to Rakuten Medical corporate infrastructure via development of SOPs, work instructions, etc.
- Develop strategy and assure compliance of devices compliance with FDA regulations and the Medical Device Directive (MDD) in the EU and other equivalent regulatory requirements at other territories
- Responsible for the review and approval of promotional, advertising, and labeling items
- Other duties as assigned
Desired Education, Skills and Experience
- Minimum of 10 years of regulatory experience in US/OUS (EU/Japan) related with pharmaceutical/device development and commercialization
- Experience in oncology programs and accelerated approvals
- S. / M.S. degree or higher in a life science field is minimum. Ph.D. or equivalent is highly desired. RAC accreditation is desirable
- Experience in representing the sponsor and interfacing with the FDA, EMA and PDMA
- Demonstration of successful submissions of INDs, NDAs, BLAs and/or PMAs; experience with drug-device combinations is desirable
- Experienced in cGMP of biologics
- Extensive knowledge of US FDA/EMA drug/device development process, regulations and guidelines, including GCP. Solid knowledge of Quality Assurance and PAI preparations
- Good understanding of Quality Assurance and Quality Management Systems to ensure adherence to cGMP and GLP requirement and SOP’s
- Good conceptual, strategic, analytical, problem solving, and organizational skills
- Ability to operate independently and proactively, to provide insight into specific regulatory issues within the context of the ongoing and future programs. To proactively undertake background research needed and to propose effective and creative solutions
- High emotional intelligence, sound temperament and professional attitude. Good common sense and judgment. Broad business perspective to integrate Regulatory Affairs concepts as part of the overall corporate strategy
- Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering, manufacturing, sales and marketing, and administration
- Outstanding leadership and management capabilities to build, motivate and manage a strong quality organization. Personal alignment with Rakuten Medical’s values, mission and vision
- Assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done
The expected salary range for this position based in California is $250,000 to $300,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.
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. We recommend anyone coming onsite to be vaccinated for COVID-19. Rakuten Medical 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.
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 Medical 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.