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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and implementing regulatory strategies for drug submissions in Japan, with a strong focus on compliance and risk management. Proven ability to lead interactions with Japanese Health Authorities and collaborate effectively with R&D stakeholders.
Highest-signal resume keywords
Regulatory Affairs ExperienceRegulatory Strategy DevelopmentRegulatory Submissions LeadershipJapanese Health Authorities InteractionRisk Assessment and Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory StrategyRegulatory ComplianceDrug DevelopmentClinical ResearchSubmission Document PreparationLife Cycle ManagementRisk Mitigation StrategiesRegulatory Guidelines UnderstandingProject Team LeadershipStakeholder Collaboration
Soft Skills
LeadershipCommunicationStrategic ThinkingCollaborationProblem Solving
Industry Keywords
BiotechnologyPharmaceuticalsRegulatory AuthoritiesJapanHealth Sciences
About the role
Key responsibilities & impact- Contribute to the development and implementation of regulatory strategy for specific projects
- Serve as the regulatory representative from Japan on relevant project teams
- Serve as regulatory contact with relevant regulatory authorities
- Manage preparation of submission documents and approval of new drugs, including life cycle management in Japan
- Lead development, alignment, and implementation of Japan regulatory strategy across all development stages
- Provide end-to-end leadership for regulatory submissions in Japan
- Lead meetings and interactions with Japanese Health Authorities
- Translate authority feedback into actions and strategic recommendations
- Identify, assess, and communicate regulatory risks and opportunities
- Develop mitigation and escalation strategies
- Provide recommendations balancing regulatory compliance with risks and benefits of innovative approaches
Requirements
What you’ll need- BA/BS/University degree required; Life/Health Sciences preferred
- 10+ years of biotechnology or pharmaceutical experience
- 5–7 years’ experience in regulatory affairs or equivalent experience/education
- Strong understanding of regulation, guidelines, and trends
- Clinical research and drug development experience preferred
- Ability to develop, align, and implement Japan regulatory strategy
- Experience leading regulatory submissions and interactions with Japanese Health Authorities
- Ability to assess and communicate regulatory risks and opportunities
- Ability to collaborate with R&D stakeholders and lead project teams
Benefits
Comp & perks- Learning, growth, and opportunities to expand skills
- Inclusive and belonging-focused workplace culture
- Opportunity to make a significant impact
- Stability and resources of a well-established biotechnology company