Director/Senior Director of Global Regulatory Affairs

Director/Senior Director of Global Regulatory Affairs Director/Senior Director of Global Regulatory Affairs – Rakuten Medical 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 for terminal cancer patients. This first‑in‑class product has unique pharmacological activity and stands to have 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, the company has locations in the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten‑med.com. 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. Major responsibilities 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. 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 from early‑stage (IND/CTA) through NDA/BLA and lifecycle management. Documentation & Compliance: Ensure compliance with all applicable global laws, regulations and standards (e.g., 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 regulatory vendors and contractors toward budget‑ and time‑efficient completion of corporate goals. 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. 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. 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. 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 tracking. Qualifications Education: Advanced degree in Life Sciences, Pharmacy, Regulatory Affairs or related discipline (M.S., Ph.D. or Pharm.D.). Experience: 10+ years regulatory affairs experience in the biopharmaceutical industry, with at least 5 years in a leadership role. Proven track record 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. Benefits & Compensation We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401(k), medical, dental, vision plans and more. 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. Vaccination for COVID‑19 is recommended for onsite employees. Equal Opportunity Statement 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. Seniority Level Director Employment Type Full‑time Job Function Legal Industries Biotechnology #J-18808-Ljbffr