Director/Senior Director of Global Regulatory Affairs
Rakuten Medical
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $150,000 - $190,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Develop and execute integrated regulatory strategies that optimize approval pathways for drug and device across all regions where clinical studies are conducted.
- Lead cross-functional teams to prepare high-quality regulatory submissions.
- Ensure compliance with all applicable global laws, regulations, and standards (eg FDA CFR, EMA guidelines, ICH, PMDA standards, EU MDR/IVDR, GCC regulations).
- Develop regulatory project plans and timelines; coordinate submission team and regulatory department meetings.
- 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.
- Monitor regulatory commitments, deliverables, and submission content across regions.
Requirements
- 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.
- Experience in oncology or biologics preferred; combination product/device experience is a plus.
- 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).
Benefits
- flexible time off
- stock options
- 401k
- medical
- dental
- vision plans
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategy developmentregulatory submissionslifecycle managementdocument reviewsubmission planningoncologybiologicscombination product/device experienceglobal regulatory frameworksICH guidelines
Soft skills
leadershipcross-functional team collaborationcommunicationorganizational skillsproject management
Certifications
advanced degree in Life SciencesPharmacyRegulatory Affairs