Regulatory Affairs Specialist

As a Regulatory Affairs Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• 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 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.

• You are:
  
  

  • G-Bachelor's Level Degree
  • Good English skills 
  • 2-3 years of experience

   

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, 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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.