Rakuten Medical · 1 month ago
Director/Senior Director of Global Regulatory Affairs
San Diego, CA
Full-time
Onsite
Director/Executive
$150K/yr - $190K/yr
10+ years expRakuten Medical, Inc. is a global biotechnology company focused on developing precision therapies for cancer. The Director/Senior Director of Global Regulatory Affairs will lead the development and execution of global regulatory strategies, ensuring compliance with international regulations while collaborating with cross-functional teams.
BiotechnologyHealth CareMedicalService IndustryTherapeutics
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 tracking
Qualification
Required
Advanced degree in Life Sciences, Pharmacy, Regulatory Affairs, or related discipline (M.S., Ph.D., or Pharm.D.)
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
Deep understanding of global regulatory frameworks (FDA, EMA, PMDA, and other major health authorities)
Familiarity with ICH guidelines, GCP, and evolving regulatory trends
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)
Ability to anticipate regulatory challenges and develop proactive solutions aligned with business objectives
Skilled at leading cross-functional teams and influencing stakeholders across global regions
Exceptional written and verbal communication skills for health authority interactions and internal alignment
Strong organizational skills with the ability to manage multiple priorities and meet tight deadlines
Analytical mindset to resolve complex regulatory issues and adapt to changing requirements
Commitment to ethical standards and regulatory compliance in all activities
Preferred
Experience in oncology or biologics preferred; combination product/device experience is a plus
Benefits
Flexible time off
Stock options
401k
Medical
Dental
Vision plans
Company
Rakuten Medical
Rakuten Medical is a biotechnology company developing investigational cancer therapies based on its proprietary Alluminox platform.
51-200 employees
H1B Sponsorship
Rakuten Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
$837.59MKey Investors
TaiAxAMEDGeneral Catalyst
2026-01-07Series F· $100M
2025-06-04Grant
2024-03-06Series E· $119M
Leadership Team
C
Carlos A. Garcia
Chief Technical Officer
Recent News
2026-01-16
2026-01-11
Company data provided by crunchbase