Regulatory Affairs Specialist

Position Name : Regulatory Affairs Specialist

Location : Tokyo, Japan

Job Description : 

・Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.

・As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

・Travel (approximately 10%) domestic and/or international

・To be familiar with and to work in accordance with relevant ICON SOP's and internal systems, GXP and appropriate regulations and guidelines.

・Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken.

・Undertake all required tasks requested to meet departmental and project goals, as appropriate.

・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 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 dept 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 .

・Other duties as assigned.

Qualification :

・Knowledge of relevant regulations regarding drug development

・High business level English; Fluency in Japanese

・Previous experience in new drug development and regulatory submissions (5+ years)

・High problem-solving skill, project management skill, leadership quality

Benefits of Working in ICON

 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career. 
 
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