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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory strategy development and complex regulatory document authoring, with a strong understanding of global clinical development regulations. Proven ability to mentor junior staff and effectively communicate with cross-functional teams while managing health authority interactions.
Highest-signal resume keywords
Regulatory Affairs ExperienceGlobal Clinical Development RegulationsScientific Writing SkillsHealth Authority InteractionsCross-Functional Collaboration
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 Strategy DevelopmentComplex Regulatory Document AuthoringClinical Trial ApplicationsRisk Management StrategiesCMC DocumentationRegulatory Input into Clinical Development PlansRegulatory Guidelines InterpretationAnalytical SkillsAttention to DetailHealth Authority Submission Support
Soft Skills
Communication SkillsCollaboration SkillsMentoring SkillsCritical Thinking SkillsPresentation Skills
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointCopilot
Industry Keywords
PharmaBiotechCROFDAEMAICHRegulatory ScienceClinical DevelopmentRegulatory ComplianceHealth Authority Interactions
About the role
Key responsibilities & impact- Lead or significantly contribute to regulatory strategy development for clinical programmes and key milestones
- Author and review complex regulatory documents, including clinical trial applications, briefing documents, and major submission components
- Interpret global regulations, guidelines, and precedents and advise cross-functional teams on regulatory expectations and risk
- Participate in or lead health authority interactions, including meeting preparation, presentation support, and follow-up
- Provide regulatory input into clinical development plans, risk management strategies, and labelling considerations
- Mentor junior regulatory staff and contribute to internal standards, templates, and best practices
- 薬事関連資料（各種面談資料、治験届等）の作成
- 当局との連携・新薬申請から承認取得までの各種対応・進捗管理
- 社内他部門との連携と薬事観点のアドバイス提供
- 薬事戦略の提案やプレゼンテーション
- 新規事業獲得にむけてクライアントへのアプローチ
- CMC関連文書作成・CMCコンサルティング全般
- 業務関連通知・規制アップデートの全体共有
- Managerと複数名のチームを組んで業務プロジェクトに対応
Requirements
What you’ll need- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Substantial experience in regulatory affairs or regulatory science within pharma, biotech, or CRO
- Strong understanding of global clinical development regulations and guidance, including FDA, EMA, and ICH
- Excellent scientific writing, analytical, and critical-thinking skills, with meticulous attention to detail
- Proven experience supporting or leading health authority interactions and complex submissions
- Strong communication and collaboration skills, with the ability to work effectively in cross-functional teams
- Willingness to travel as required, approximately 5%
- 3年以上の規制当局との折衝やコミュニケーション、円滑なやり取りなどの実務経験
- 英語でのコミュニケーションスキル、文書作成能力
- 言語ビジネスレベルの英語力
- Microsoft Word / Excel / PPTを業務で使用できること
- Copilotを使用した文献調査の経験があれば尚良し
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways