Regulatory Affairs Specialist

As a Regulatory Affairs Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Regulatory Affairs Specialist is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements. The Specialist will assist the Regulatory Affairs team member on cross-functional projects and will manage regulatory submissions and regulatory archive.

What you will be doing:

• Prepare, compile and submit clinical trial application and amendment dossiers for Taiwan and Hong Kong if necessary.
• Develop and manage clinical trial submission plans/strategies, and subsequent amendment applications.
• Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
• Liaise with officials of Government agencies to facilitate evaluation processes and respond to requests for data in agreed timeline.
• Maintain good knowledge of relevant corporate policies and local regulations and ensure compliance. Keep abreast of regulatory changes and evaluate the impacts on the business and communicate changes timely to related stakeholders.
• Perform TMF QC for regulatory activities, complete archiving requests/checks for regulatory submissions, and conduct the study/task-based trainings per needs
• Maintain regulatory tracking system for clinical trial submissions to ensure clear record and archive.
• Assist line manager to complete assignment as requested in a timely manner.

You are:

• Understanding IND process with a thorough knowledge of ICH and associated regulatory guidelines.
• With a minimum of 1 year of IND regulatory affairs experience
• Excellent organizational skills and ability to prioritize and multi-task.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.

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.

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