Regulatory Affairs Specialist

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