Regulatory Affairs Associate

Study Start Up Associate I- IND Submission-Home based-South Korea- ICON Strategic Solutions

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 Study Start Up Associate I to join our diverse and dynamic team. As a Study Start Up Associate I at ICON, you will play a pivotal role in facilitating the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNvative treatments and therapies.

What you will be doing

• Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.

• Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.

• Maintaining accurate and up-to-date records of regulatory submissions and approvals.

• Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.

• Participating in study start-up meetings and providing input on regulatory requirements and timelines.

Your profile

• Bachelor's degree in life sciences or a related field.

• Previous experience in clinical research or regulatory affairs preferred, but Nt required.

• Strong attention to detail and organizational skills.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

• Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.

• This position is related Regulatory Affairs

• IND Submission, CMC Experience

• Home-Based

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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