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.
Regulatory Scientist
Location
Mexico
Posted
58 days ago
Salary
0
Seniority
Mid Level
Job Description
Regulatory Scientist
ICON plc
Home based position ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Regulatory Scientist to join our diverse and dynamic team. As a Regulatory Scientist at ICON, you will support the development, implementation, and execution of regulatory strategies for clinical development programmes in Canada. You will contribute scientific and regulatory expertise to ensure submissions meet global requirements and support successful product development. What You Will Be Doing: - Contributing to regulatory strategy development for clinical programmes, including plans for health authority and central ethics interactions and submissions. - Preparing, reviewing, and coordinating regulatory documents such as clinical trial applications, briefing packages, and responses to health authority and central ethics questions. - Ensure deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles. - Track and file central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable systems ensuring accuracy and completeness of data/documents entered - Collaborating with clinical, safety, CMC, and other cross-functional teams to ensure alignment of regulatory content and messaging. - Monitoring changes in the regulatory environment and providing guidance on potential impact to programmes and submissions. - Supporting regulatory interactions and meetings, including preparation of materials and documentation of outcomes. Your Profile: - Degree in life sciences, pharmacy, or a related field, or equivalent scientific and regulatory experience. - Experience in regulatory affairs, regulatory writing, or clinical development within the pharma, biotech, or CRO industry. - Good understanding of global regulatory frameworks and guidelines relevant to clinical development. - Strong scientific, analytical, and critical thinking skills, with the ability to interpret complex data and regulations. - Excellent written and verbal communication skills, with high attention to detail and accuracy. - Ability to work effectively in cross-functional teams and manage multiple regulatory activities and timelines. - Read, write and speak fluent English What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - 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. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
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Senior Global Regulatory Scientist
ICON plcICON 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.
Homebased role ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Global Regulatory Scientist to join our diverse and dynamic team. As a Senior Global Regulatory Scientist at ICON, you will provide high-level regulatory and scientific expertise to support global development strategies and submissions. You will collaborate with sponsors and cross-functional teams to navigate complex regulatory pathways and enable successful product development. What You Will Be Doing: - Leading the development of global regulatory strategies for clinical programmes, including plans for key health authority interactions and milestones. - Authoring and reviewing complex regulatory documents such as clinical trial applications, briefing books, and major submission components. - Interpreting evolving global regulations, guidelines, and precedents, and advising teams on implications for programme design and execution. - Providing strategic input into clinical development plans, risk management strategies, and labelling considerations. - Representing regulatory functions in sponsor and health authority meetings, ensuring clear, scientifically robust communication. - Mentoring junior regulatory colleagues and contributing to internal best practices, templates, and knowledge-sharing initiatives. Your Profile: - Bachelor's degree in life sciences, pharmacy, medicine, or a related discipline, or equivalent regulatory experience. - 4+ years experience in regulatory affairs or regulatory science within pharma, biotech, or CRO environments. - Strong knowledge of global clinical development regulations (e.g., FDA, EMA, ICH) and regional requirements. - Excellent scientific, analytical, and critical-thinking skills, with the ability to integrate complex data into regulatory positions. - Outstanding English written and verbal communication abilities - Proven experience interacting with health authorities and leading cross-functional regulatory projects What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - 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. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

