Regulatory Affairs Job at ICON
Looking for an exciting Regulatory Affairs Job with a leading global clinical research organization? ICON Careers has opened applications for the position of Senior Study Start Up Associate – Regulatory Affairs. This opportunity is ideal for professionals with experience in clinical study start-up, IND submissions, and regulatory compliance who are seeking rewarding Clinical Research Jobs in an international, remote working environment.
About the Company:
ICON plc is a world-leading healthcare intelligence and clinical research organization that partners with pharmaceutical, biotechnology, and medical device companies to accelerate the development of innovative therapies. With operations across the globe, ICON combines scientific expertise, advanced technology, and patient-focused solutions to support every stage of clinical development. Through ICON Careers, professionals can build meaningful careers while contributing to life-changing clinical research and healthcare innovation.
Job Details:
- Position: Senior Study Start Up Associate – Regulatory Affairs
- Job Reference: JR155158
- Division: Study Start Up
- Work Arrangement: Remote
- Location: Seoul, South Korea (Home-Based)
Job Description:
ICON Strategic Solutions is hiring a Senior Study Start-Up Associate – Regulatory Affairs to support global clinical development activities. This Regulatory Affairs Job focuses on regulatory submissions, study start-up activities, ethics approvals, site activation, and ensuring compliance with country-specific regulations.
The selected candidate will collaborate with Study Start Up teams, project managers, regulatory authorities, and ethics committees to ensure timely activation of clinical studies while maintaining the highest standards of quality and regulatory compliance.
Key Responsibilities:
- Lead study start-up and site activation activities.
- Conduct site feasibility assessments and site identification.
- Coordinate site contract negotiations.
- Prepare and manage submissions to regulatory authorities and ethics committees.
- Ensure compliance with local and international regulatory requirements.
- Support IND submission and CMC documentation activities.
- Develop and review Subject Information Sheets and Informed Consent Forms.
- Provide regulatory expertise to Study Start Up team leads and project teams.
- Drive continuous quality improvement throughout study start-up.
- Collaborate with cross-functional global teams to achieve project milestones.
Educational Requirements for this Regulatory Affairs Job:
Essential Qualification
- Bachelor’s degree or equivalent in Medical Sciences or a related discipline.
Experience
- Minimum 3 years of experience in clinical study start-up and regulatory affairs.
- Experience with IND submissions and CMC documentation.
- Strong understanding of clinical trial regulations and ethics submission processes.
Language Requirements
- Fluency in the local language (Korean).
- Excellent written and spoken English.
Skills Required for this Regulatory Affairs Job:
- Regulatory affairs expertise.
- Clinical study start-up management.
- IND submission experience.
- Ethics committee submission knowledge.
- Strong project coordination skills.
- Excellent communication and stakeholder management.
- Knowledge of ICH-GCP and regulatory guidelines.
- Attention to detail and documentation accuracy.
- Ability to work independently in a remote environment.
- Continuous improvement mindset.
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