Senior Manager Regulatory Affairs

Senior Manager Regulatory Affairs

Dublin or United Kingdom

Icon are looking to hire a Senior Regulatory professional who will contribute to drug development, as part of the Regulatory Affairs team, through provision of regulatory guidance and operational support to early drug development, agency interactions, clinical trial applications, marketing applications and post approval support

The Senior Manager Regulatory Affairs will be a Regulatory professional with in-depth Regulatory affairs experience and the ability to lead internal teams and carry out complex regulatory activities and submissions independently

Contributes to ICON Regulatory Affairs through their understanding of Regulatory process and interpretation of guidelines to develop best practices

Your Responsibilities and Accountabilities:

Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken and be capable of supporting or developing regulatory strategies or solutions as appropriate to level of expertise

As member of the Regulatory Affairs team, you will be required to have in-depth experience with at least one of the following activities, and aim to gather experience in several, working mainly independently;

• Preparation, compilation and submission of routine Regulatory submissions e.g. CTA /IND, Variations / lifecycle submissions, Annual reports to IND, orphan designation or PIP
• Be Client POC/ Alliance POC for complex CTA programmes and ICON Alliance partners
• Be responsible for Agency submissions (e.g. IND, CIND, Japan CTN, new EU CTR submissions)
• Leads specialised submission preparations and Agency interactions (Adaptive Pathways, Fast track Designation, priority review)
• Leads preparation and review of Agency Briefing documents as well as provision of strategic advice to clients, preparation and attendance at national Agency meetings and follow up 
• Take a major, client facing role in  more complex projects (early development, MAA/NDA, Post Marketing), provides Regulatory Strategy and input to development of Scientific advice/Agency meetings//MAA/NDA/BLA, product label review,
• Lead Regulatory Intelligence Function
• Lead ICON and department level initiatives to develop and improve processes
• Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within GRA/ICON
• Communicate /liaise with clients, regulatory agencies / competent authorities and/ or other regulatory or functional experts on designated regulatory activities as required

• Bachelor’s degree or local equivalent, in the sciences or relevant discipline or equivalent experience qualification.
• Strong organizational skills, ability to manage multiple tasks by setting/agreeing on priorities and meticulous attention to detail.

Next Steps:

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON Plc is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment