Director/Senior Director of Global Regulatory Affairs

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. 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 for full time employees. 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. Apply for this job * indicates a required field First Name * Last Name * Email * Phone Country * Phone * Resume/CV * Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Website Current Address: * Driver's License Number and State of Issuance: * Are you willing to relocate? * Select... Are you at least 18 years of age? If hired, you will be asked to produce proof of age and work permit if necessary. * Select... Do you require work authorization sponsorship? * Select... Without telling us which one, are you a United States citizen, noncitizen national, lawful permanent resident, or an alien authorized to work in the United States? * Select... Do you have any professional

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