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About the Role
As a Senior Regulatory Scientist at ICON, you will provide advanced regulatory and scientific expertise to support global clinical development strategies, submissions, and health authority interactions. You will help navigate complex regulatory landscapes to enable successful programme execution.
Responsibilities
- Take ownership of regulatory affairs deliverables, applying expertise to complex challenges.
- 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 interactions with health authorities, 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.
- Prepare regulatory affairs documents (e.g., meeting materials, clinical trial applications).
- Liaise with regulatory authorities and manage all processes from new drug application to approval.
- Collaborate with other internal departments and provide advice from a regulatory affairs perspective.
- Propose and present regulatory strategies.
- Approach clients for new business acquisition.
- Prepare CMC-related documents and provide general CMC consulting.
- Share overall business-related notifications and regulatory updates.
Requirements
- 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 (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.
- Strong communication and collaboration skills, with the ability to work effectively in cross-functional teams.
- Willingness to travel as required (approximately 5%).
- 3+ years of experience in one of the following areas: negotiation and communication with regulatory authorities, including practical experience in smooth communication.
- Business-level English communication skills and document creation ability.
- Ability to understand shared items in online meetings with overseas clients/global teams, report on the situation in Japan, and respond to Q&A.
- Ability to use Microsoft Word, Excel, and PowerPoint for business purposes.
- Experience with literature research using Copilot is a plus.
- Must have the legal right to work in the country where the role is based.
Skills
- Regulatory Affairs
- Regulatory Science
- Clinical Development
- Submission Support
- Health Authority Interactions
- Scientific Writing
- Analytical Skills
- Critical Thinking
- Communication Skills
- Collaboration Skills
- Cross-functional Teamwork
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Copilot (for literature research)
Location
- Tokyo
- Osaka
- Home
Work Type
- Full remote
- Full-time
Experience Level
- Senior
- 3+ years
Education Level
- Bachelor's degree
Benefits
- 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
About the Company
- ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
- As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Equal Opportunity
- ICON is an equal opportunity employer.
- We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
- If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.