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About the Role

ICON is a global healthcare intelligence and clinical research organisation focused on accelerating the delivery of new medicines and treatments to patients. As a Senior Regulatory Scientist, you will leverage advanced regulatory and scientific expertise to support global clinical development strategies, submissions, and health authority interactions, navigating complex regulatory landscapes for successful program execution.

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.
Authoring regulatory documents (e.g., meeting materials, clinical trial notifications).
Liaising with authorities, managing new drug applications through to approval, and tracking progress.
Collaborating with internal departments and providing regulatory advice.
Proposing and presenting regulatory strategies.
Approaching clients for new business acquisition.
Creating CMC-related documents and providing overall CMC consulting.
Sharing notifications and regulatory updates across the organization.

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.
Proven experience supporting or leading health authority interactions and complex submissions.
Experience in regulatory authority negotiations, communication, and smooth interactions for over 3 years.
Ability to use Microsoft Word, Excel, and PowerPoint for work.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Skills

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.
Strong communication and collaboration skills, with the ability to work effectively in cross-functional teams.
Business-level English proficiency, including understanding shared items in online meetings with overseas clients/global teams, reporting on the Japanese situation, and handling Q&A.
Experience using Copilot for literature research is a plus.

Location

Tokyo
Osaka

Work Type

Office Hybrid
Home

Experience Level

Senior

Education Level

Advanced degree in life sciences, pharmacy, medicine, or a related discipline, or equivalent regulatory experience.

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.
ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide.
You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live.

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.