Director managing IT security strategies and policies for Abbott. Overseeing IT security functions and implementation of company - wide policies in a healthcare leadership role.
About the role
- Senior Regulatory Scientist providing regulatory and scientific expertise for global clinical development at ICON. Leading strategy development, authoring documents, and mentoring staff.
Responsibilities
- Leading or significantly contributing to regulatory strategy development for clinical programmes and key milestones.
- Authoring and reviewing complex regulatory documents, including clinical trial applications, briefing documents, and major submission components.
- Interpreting global regulations, guidelines, and precedents and advising cross-functional teams on regulatory expectations and risk.
- Participating in or leading interactions with health authorities, including meeting preparation, presentation support, and follow-up.
- Providing regulatory input into clinical development plans, risk management strategies, and labelling considerations.
- Mentoring junior regulatory staff and contributing 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
Requirements
- Advanced degree in life sciences, pharmacy, medicine, or a related discipline, or equivalent regulatory experience.
- Substantial experience in regulatory affairs or regulatory science within pharma, biotech, or CRO.
- Strong understanding of global clinical development regulations and guidance (e.g., FDA, EMA, 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.
- 下記の業務のいずれかを3年以上経験していること
- 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
- その他
- 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
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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