Regulatory Affairs Manager
About the role
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Manager Regulatory Affairs
Location: Dublin Ireland or London UK
ICON are currently looking for a Manager Regulatory affairs to join the Global Regulatory Affairs consulting team. Based at ICON HQ in Dublin Ireland or in the London office, you will be working with a team of Regulatory professionals who provide strategic and operational expertise to clinical trials, to drug development and to MAA/ NDA programmes. Forming part of a successful and driven team, you will act as Regulatory Project Lead in providing consultancy for ICON global projects, dealing directly with clients and Regulatory Agencies. ICON Regulatory Affairs projects cover all aspects of drug development and all areas of development
Role Summary
- A Regulatory professional who contributes 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
- Manager Regulatory Affairs is a Regulatory professional who will have prior experience with several areas of Regulatory affairs (CTA/IND/MAA) and the ability to lead internal teams and carry out regulatory activities and submissions independently
- May work as part of a regulatory or cross-functional team depending on the size and nature of project
- Contributes to ICON Regulatory Affairs through their understanding
- Regulatory process and interpretation of guidelines to develop best practices
Experience and Qualification
- A University degree in medicine, science, or equivalent is required. In addition, you will also require:
- Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner
- A minimum of five years’ experience in the pharmaceutical or pharmaceutical contract service industry within Regulatory Affairs in a similar role.
- Ability to produce accurate work to tight deadlines within a pressurised environment.
- Ability to work both independently and in a team environment.
- Proficiency with computer systems
You will have the opportunity to be exposed to a number of diverse projects and clients and to progress your career into management or into other related areas where you can further develop your skill set.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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