As a Senior Regulatory Scientist at ICON, you'll ensure clinical trial regulatory deliverables are met while mentoring junior staff. You'll play a key role in maintaining compliance and improving processes within the organization.
Collaborative and mission-driven, with a focus on integrity and inclusion.
Senior Regulatory Scientist 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. **The Role:** As a Senior Regulatory Scientist, you will be responsible for completing country and/or regional clinical trial regulatory deliverables in line with study specifics, ensuring compliance with ICH\-GCP, relevant regulations, and sound scientific principles. You will also contribute to process improvement initiatives, mentor junior staff as needed, and provide strategic input into submissions planning. **Key Responsibilities:** * Deliver regulatory submissions in accordance with contractual timelines, budget, and quality standards. * Apply advanced knowledge of ICON SOPs/WIs, ICH\-GCP, and local regulatory requirements. * Contribute to strategic planning of submissions to Regulatory Authorities (RA), Central Ethics Committees (CEC), and other applicable bodies. * Prepare, adapt, coordinate, and collate submission documentation per study and country requirements. * Manage internal and external reviews of regulatory documentation and ensure accuracy of data in systems such as CTMS and eTMF. * Oversee translation management and submission lifecycle through approval. * Maintain proactive communication with project teams to ensure timely updates on submission and approval status. * Collaborate cross\-functionally to ensure regulatory deliverables are met. * Support maintenance of up\-to\-date clinical trial regulatory intelligence across global and regional levels. * Mentor junior team members and contribute to the ongoing enhancement of ICON’s regulatory processes. **You Are:** * Educated to degree level in life sciences or related discipline. * Experienced with a minimum of **3 years’ relevant regulatory experience** in clinical research. * Fluent in **English.** * Highly organized with excellent attention to detail and ability to manage multiple priorities. * A strong communicator with the ability to engage internal teams and external stakeholders effectively. \#LI\-JJ1 Employment with ICON is contingent upon having the legal right to work in the country where the role is based. **Rewards \& Benefits** ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: * 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 Benefits may vary depending on role and location. Visit...
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