Regulatory Affairs Specialist

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

ICON is hiring talented professionals in China as our China teams are growing!

Role Responsibility

Recognize, exemplify and adhere to ICON's values which centre 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 expert ise and to meet department goals.
Specific Regulatory Submission team activities include (but are not limited to)
Input into Preparation, compilation and submission of IMPD, CT /IND, MAA I NOA, Variations/ lifecycle submissions, DSUR, PSUR, renewals, agency briefing documentation.
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.