Regulatory Affairs Specialist

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Regulatory Affairs Specialist

Seoul, Korea

Job Description:

Participate in regulatory and/or clinical trial project teams as required

Plan and track designated project activities including financial tracking under supervision

Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements

Effectively contribute to all the aspects of allocated projects in timely manner including tracking (time and resources), proactive identification of risks, scope change, financial implications and provision of solutions for approval by Managers/Directors

Be able to solve the problems in pro-active and timely manner by identifying the deficiencies in the existing processes and procedures and providing the possible solutions

Work closely with Process/Project Management team to identify process and procedure improvements and assist in implementation of continuous improvement measures to ensure department expertise and to meet department goals

Specific Regulatory Submission team activities include (but are not limited to)

Input into Preparation, compilation and submission of CT /IND, MAA I NOA, Variations/ lifecycle submissions, DSUR, PSUR, renewals, agency briefing documentation, medical device documentation, Readability testing

Input into label review, translation requirements, fee requirements, etc.

Input to the Regulatory Intelligence function

IMPD I IB Core Doc review, labeling review for clinical trial applications

Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.

Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within GRA/ICON

Identify issues and address them in a timely manner, including preventive actions. Be solution orientated and own the delivery and commitment on behalf of ICON

Responsible for timely and accurate completion of assigned projects and for timely identification of issues or the need for change orders

Be able to liaise and advise clients on the process and timelines, changes to the regulations as required ensuring timely and quality delivery of projects

Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary

Maintain an accurate record of the time associated with each activity

Travel (approximately 10%) domestic and/or international

Qualifications:

Bachelor’s Degree or higher graduate degree from the Medical/science background and/or discipline

At least 1+ years of professional experience for preparation of submission package and regulatory submissions for IND approval with full understanding of IND submission requirements and activities

Experience in communicating with MFDS as the main contact for initial IND, IND amend and notification preferred but mut a must

Experience in developing Country Informed Consent Forms and following up with Legal as needed in accordance with the protocol.

Knowledge of local regulatory requirements/guidelines and global standards, mainly for IND application

Good interpersonal communication skills

Excellent written and spoken English and fluency in Korean

Competent computer skills

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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, 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 through the form below.

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Are you a current ICON Employee? Please click here to apply: link

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