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Regulatory Affairs Specialist

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About the role

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"At ICON, it's our People that set us Apart"
 
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specializes in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 38 countries and has approximately 12,600 employees. Further information is available atwww.iconplc.com
 
Regulatory Affairs Specialist
 
Role Responsibility
 
 
  • 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.
  • 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.
 
Benefits of Working in ICON
 
  • Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
  • 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.
 
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