Key Duties and Responsibilities 

Collaborate with global clinical teams (Clinical Operations, CMC, Quality Assurance, Regulatory, etc.) and network of Clinical Development and Manufacturing Organizations to oversee end-to-end supply chain activities from phase 1-3 and IIT trials. Leads and manages clinical packaging and labeling operations / Investigational Drug, Standard of Care Drug and Medical Devices, drive clinical label creation and approvals process, including translations for applicable countries. Lead end-to-end supply chain network set-up for new and upcoming global clinical trials. Develop Supply Strategies and Inventory optimization plans per program, protocol design and region. Design, Implementation and UAT of Interactive Response Technology (IRT/IxRS) for multi-arm drug-device combination trials. Develop, implement, and update Supply Chain SOPs and Work Instructions. Co-develop device and pharmacy manual. Manage Temperature excursions, CAPA, SCARs and other quality events as applicable. Supplier Management: Standard of Care Drug Procurement, RFQ, Vendor Management, Cost saving initiatives, Negotiations, Supplier relationship/evaluation. Quarterly review of budgets vs actual spend for active studies. Provide Supply Chain support for regulatory filings including IND submission information, Import/Export Licenses filing and audits from all health agencies. Proactively report supply risk, product and material availability issues. Participate in and contribute to supply chain metrics, S&OP (Sales & Operations Planning) process. Drive Ad-hoc projects to review exceptions/changes relating to Supply Chain. This position is open to telecommuting from anywhere in California. Requires occasional presence in office. Travel required. As needed, up to 15% travel covering global  Supply Chain areas for Supply Chain Management, Clinical & Commercial Supply Chain, Manufacturing & Production Planning, and other related activities.

Requirements

Master’s degree or foreign equivalent in Supply Chain Management, Industrial, Operations, Production engineering or closely related degree and experience as an Associate Manager, Technical Operations & Supply Chain, Supply Chain Specialist, Clinical Supply Chain Coordinator or related occupation in supply chain management. APICS/ASCM Certification required (CPIM or CTL or CSCP).

Desired Education, Skills and Experience

Experience must include four (4) years of experience in all of the following:

1. Experience in global clinical supply chain management, medical device industry and developing/implementing clinical trial management technologies (eg: IxRS, IRT, etc.).
2. Experience in forecasting, supply planning, optimizing inventory, S&OP process, scenario planning, production planning & scheduling, CMO management, regulatory requirements relating to clinical labeling, packaging, and distribution activities.
3. Working under a highly regulated cGMP and GCP manufacturing environment.
4. Designing and setting up complex supply chain networks within strict FDA compliance, GLP, GCP and GDP frameworks.

Or an alternative Bachelor’s degree or foreign equivalent in Science in Supply Chain Management, Industrial, Operations, Production Engineering or a closely related degree and experience as an Associate Manager, Technical Operations & Supply Chain, Supply Chain Specialist, Clinical Supply Chain Coordinator or related occupation in supply chain management. APICS/ASCM Certification required (CPIM or CTL or CSCP).                                

Experience must include six (6) years of experience in all of the following:

1. Experience in global clinical supply chain management, medical device industry and developing/implementing clinical trial management technologies (eg: IxRS, IRT, etc.).
2. Experience in forecasting, supply planning, optimizing inventory, S&OP process, scenario planning, production planning & scheduling, CMO management, regulatory requirements relating to clinical labeling, packaging, and distribution activities.
3. Working under a highly regulated cGMP and GCP manufacturing environment.
4. Designing and setting up complex supply chain networks within strict FDA compliance, GLP, GCP and GDP frameworks.

Salary: $149,282.00 annually

Job Requisition #277

Opened: 08 APR 2026

Company Profile

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 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.  

Position Summary

The Manager/Senior Manager of Clinical GCP Quality will be responsible for evaluating and mitigating risk of the global clinical development programs, from initiation through completion of clinical trials, with inspection readiness in mind throughout. The ideal candidate will advise on company clinical quality strategy, ensure compliance to regulations, oversee quality management systems and interact directly with cross functional clinical, regulatory and quality teams. The ideal candidate will have at least 10 years of experience in clinical quality, process improvement, regulatory inspection management and at least two years of clinical auditing experience as lead auditor. The candidate will have an excellent working knowledge of Good Clinical Practices (ICH E6), quality requirements and other international regulations (e.g. US, EU, Taiwan, India, Japan) are desirable.

Key Duties and Responsibilities

• Provide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activities.

• Successfully lead global and cross-functional quality projects

• Maintains current knowledge of ever-changing clinical quality guidance and regulations.

• Excellent communication and people skills to ensure cohesive and collaborative teamwork. 

• Demonstrated ability to implement and collaboratively drive company initiatives and policies.

• Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections. Lead Quality hosting clinical site inspection by regulatory agencies highly preferred.

• Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close).

• Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as well as direct and guide audit follow-up actions. 

• Establish Quality and Cross-Functional SOPs, processes and associated documents. 

• Working closely with clinical pharmacovigilance team on supporting clinical trial safety. 

• Responsible for presenting & updating CGP quality metrics and reporting to Sr. Management. 

• Other duties as assigned. 

Desired Education, Skills and Experience

• B.S. Degree in life sciences with advanced degree in a scientific discipline preferred.
• Minimum of 10 years direct experience in GCP Quality Assurance and/or GCP Compliance.
• Minimum of two years of GCP auditing (e.g. clinical site/clinical vendor) as lead auditor experience preferred.
• Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA review of clinical documents.
• Previous experience with oncology, combination drug-device studies, and/or multi-regional with US based clinical trial experience is a plus.
• Pharmacovigilance/Safety QA experience is a plus.
• Medical Device GCP experience is a plus.
• ISO Standard (e.g. ISO13485, ISO9001, ISO27001) understanding is a plus.
• Medical Device Reporting (MDR) – FDA 21 CFR Part 803.
• Pharmacovigilance laws -EU Regulation 520/2012 for drug safety monitoring.
• Experiences with Clinical Quality Management on a risk-based approach is needed.
• Electronic TMF, document, quality, and learning management systems experience
• Strong organizational and project management skills.
• Flexible thinking and team-oriented communication and coordination skills to be able to collaborate in a team environment.
• Professional working proficiency in English

REQUIREMENTS:

Physical Demands

• None, other than those necessary to perform the essential job functions

Manual Dexterity

• None, other than those necessary to perform the essential job functions

Audible/Visual Demands

• Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.

Environment

• None, other than those necessary to perform the essential job functions.

Travel

• Up to 30%

The expected salary range for this position based in California is $150,000 to $170,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

Position Summary

The Director/Senior Director of Global Regulatory Affairs (GRA) will report to the Senior Vice President of Regulatory Affairs and serve as a key leader in shaping and executing global regulatory strategies. This role will partner closely with the GRA team and cross-functional stakeholders to ensure compliance with international regulatory requirements and alignment with company objectives. The candidates major responsibilities will include the following:

• Regulatory Strategy & Advice: Develop and execute integrated regulatory strategies that optimize approval pathways for drug and device across all regions where clinical studies are conducted. Provide expert guidance on global regulatory requirements, life cycle management and evolving policies where RM is pursuing development and commercialization.

• Submission Oversight: Lead cross-functional teams to prepare high-quality regulatory submissions. Review and ensure consistency of regulatory documents with company strategy and health authority standards; manage submission strategies for all Rakuten Medical projects from early-stage (IND/CTA) through NDA/BLA and lifecycle management. Oversee planning and execution of global regulatory authority meetings, including briefing packages, strategy, positioning, and negotiations.
• Documentation & Compliance: Ensure compliance with all applicable global laws, regulations, and standards (eg FDA CFR, EMA guidelines, ICH, PMDA standards, EU MDR/IVDR, GCC regulations). Maintain regulatory filing and archiving systems; ensure documentation meets health authority requirements and guidance.
• Project Management: Develop regulatory project plans and timelines; coordinate submission team and regulatory department meetings; track goals, action items, and submission progress. Manage various regulatory vendors and contractors toward budget- and time-efficient completion of corporate goals. Proven ability to apply strong influence skills in leading cross-functional regulatory submission teams.
• Cross-Functional Collaboration: Work closely with teams in CMC, nonclinical, clinical development, medical writing, safety/PV, quality assurance, medical affairs, and program management to support timely and compliant submissions. Assess regulatory risk and drive mitigation strategies to support business continuity.
• Global Tracking: Monitor regulatory commitments, deliverables, and submission content across regions.

This position spans all functional areas requiring regulatory input, including early research, CMC, device, nonclinical, clinical development and commercial. The ideal candidate will bring strong leadership, strategic thinking, and deep knowledge of global regulatory frameworks to drive successful outcomes.

Key Duties and Responsibilities 

• Develop and execute integrated global regulatory strategies for drug and device programs across all regions as required.
• Maintain a thorough understanding of current and emerging global and regional regulations, guidance documents, and ICH standards for all application types and procedures, in all regions where the organization seeks to develop and commercialize products.
• Stay informed on regulatory requirements for biologics and combination products across all regions.
• Develop and manage submission strategies for all Rakuten Medical projects and planned submissions. Ensure regulatory documents are scientifically sound, consistent, and aligned with company strategy and health authority expectations.
• Coordinate and oversee the planning, preparation, and delivery of regulatory submissions throughout the product lifecycle—from preclinical and IND/CTA through clinical development, NDA/BLA, and ongoing lifecycle management.
• Serve as the primary interface with publishing and other regulatory vendors; review submissions for completeness and compliance with regulatory guidance and health authority expectations.
• Lead implementation of new regulatory systems and develop associated processes and SOPs.
• Manage regulatory project tracking tools to monitor deliverables, commitments, submission content, amendment and approval dates, and provide proactive status updates for all regions.
• Act as the primary regulatory lead on assigned project teams, providing strategic input and regulatory support.
• Ensure timely storage and archiving of regulatory documentation in a manner that facilitates efficient retrieval.
• Conduct regulatory review of external-facing materials (e.g., manuscripts, posters) as appropriate.
• Review clinical, CMC, and safety documentation to ensure regulatory compliance and completeness during authoring and finalization.
• Coordinate safety reporting and collaborate with Safety/Pharmacovigilance to ensure systems are in place for efficient tracking and reporting of safety information.
• Assist with onboarding new employees and manage consultants and related contracts as needed.
• Contribute to continuous improvement of operational processes for regulatory submissions and document trackin. 

Qualifications:

• Education:
  • Advanced degree in Life Sciences, Pharmacy, Regulatory Affairs, or related discipline (M.S., Ph.D., or Pharm.D.).

• Experience:

• • 10+ years of regulatory affairs experience in the biopharmaceutical industry, with at least 5 years in a leadership role.
  • Proven track record of managing global regulatory submissions (IND/CTA, NDA/BLA, MAA) and lifecycle management.
  • Experience in oncology or biologics preferred; combination product/device experience is a plus.

• Knowledge:

• • Deep understanding of global regulatory frameworks (FDA, EMA, PMDA, and other major health authorities).
  • Familiarity with ICH guidelines, GCP, and evolving regulatory trends.

• Technical Skills:

• • Expertise in regulatory strategy development and execution.
  • Strong document review and submission planning skills.
  • Proficiency with regulatory information management systems and electronic submission platforms (eCTD).

Key Competencies:

• Strategic Thinking: Ability to anticipate regulatory challenges and develop proactive solutions aligned with business objectives.
• Leadership & Collaboration: Skilled at leading cross-functional teams and influencing stakeholders across global regions.
• Communication: Exceptional written and verbal communication skills for health authority interactions and internal alignment.
• Project Management: Strong organizational skills with the ability to manage multiple priorities and meet tight deadlines.
• Problem-Solving: Analytical mindset to resolve complex regulatory issues and adapt to changing requirements.
• Integrity & Compliance: Commitment to ethical standards and regulatory compliance in all activities.

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.

The expected salary range for this position based in California is $150,000 to $190,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

Position Summary

This position plays a critical role in strengthening and accelerating the global medical and scientific impact of Rakuten Medical’s Alluminox platform. Key responsibilities include designing and delivering training programs to external Health Care Professionals and internal teams in clinical development, operation and medical affairs/science functions. This role ensures that Alluminox technology is delivered to patient at the highest standard while gathering frontline feedback from medical society to enhance Rakuten Medical’s research, development and commercialization efforts.

Key Duties and Responsibilities 

• Design, organize, lead and execute training sessions for care professionals on product knowledge effectively
• Ensure patients globally in both clinical trial and commercial settings are treated at the highest standards and if necessary to provide onsite support
• Plan, organize, and execute Investigator Meetings, Advisory Board Meetings and other equivalent events and present on behalf of the company as needed
• Support research, development and commercialization efforts through collecting and synthesizing observation in the medical field and clinicians’ feedback
• Develop robust partnership relationship with HCPs within current and future therapeutic area
• Educating employees the insights and information gained from academic papers and conference
• Identify challenges for the mid to long-term global R&D and medical communication and propose/execute solutions from medical perspective.

Desired Education, Skills and Experience

• M.D. degree and surgeon experience required
• Specialty in otorhinolaryngology, gynecology or hepatology is a plus
• 10-year + Medical affair and / or R&D related experiences in healthcare industry required
• Demonstrated hands-on characteristics and proactiveness
• Focused on actions, problem-solving and result oriented
• Ability to establish strong partnership rapport with key internal and external stakeholders
• Capability to effectively collaborate with cross-functional team and communicate with leadership team
• Solid knowledge of the healthcare landscape such as hospital systems, various points of care, and the roles of relevant HCPs in the target Tas and the drug development process
• Exceptional self-management ability and able to self-motivate
• Strong understanding of compliance, and the legal and regulatory landscape as they relate to HCP interactions
• Fluent in Medical English listening, speaking, writing and reading is a must, other second language is a plus
• May require travel up to 50%

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.

The expected salary range for this position based in California is $180,000 to $220,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.