Regulatory Affairs Specialist
Seoul, Korea
Are you ready to be a part of a successful study delivery team? ICON's award-winning study execution capabilities have led to the approval of 18 of the world's top 20 best-selling drugs. Make your experience count for the benefit of patients worldwide. www.iconplc.com
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
・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.
・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
・Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary
Qualifications:
・ Bachelor's Degree or higher graduate degree from the Medical/science background and/or discipline
・ At least 5+ 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
・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
In comparison with our competitor's and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer's to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market. We are more like an extended family with consideration of staff as individuals allowing a work-life balance.
Additionally, we have cutting edge technology that will allow you to analyze study specific processes, audit reports, and governance to quality system checks and ensure compliance.
What's Next
Following your application, if you have the necessary skills and experience for this job you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment