Regulatory Affairs Specialist generating regulatory submissions and managing compliance for medical device engineering projects at Teleflex. Ensuring adherence to FDA and Health Canada regulations with effective project timelines.
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
Field Compliance Summer Associate supporting agronomic research and development in canola at BASF's Agricultural Solutions team in Alberta. Involves data collection, crop monitoring, and field logistics.
Risk & Compliance Senior Associate role with Davy in Dublin. Overseeing regulatory compliance and contributing to risk management in financial services.
Administrative Assistant supporting office administration and compliance processes at a healthcare company. Engaging in tenders and documentation management across multiple regions.
Quality and Regulatory Specialist managing quality management systems for medical devices at SOFMEDICA. Ensuring compliance with regulations and overseeing audits and supplier qualifications.
Senior Regulatory Scientist at ICON providing expertise to support global clinical development strategies and submissions. Navigating regulatory landscapes to enable successful program execution.
Director of Compliance at Barclays overseeing operations and compliance initiatives in India. Providing expert insights and leading teams to implement compliance policies and procedures.
Compliance Data Specialist ensuring accurate regulatory submissions for Biffa's customers. Key role in data analysis, validation, and standardisation for compliance.
Regulatory Manager overseeing the preparation and submission of documents to global health authorities. Ensuring timely regulatory submissions in a collaborative biotech environment.
Field Compliance Supervisor working on OSA framework contract in the Inner M25 region. Supervising safety and compliance for Telent's network services in London.