Director, Regulatory Affairs
- Experience Level
- Experienced (non-manager)
Director, Regulatory Affairs
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.
Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.
As a Director, Regulatory Affairs, you will be expected to recognize the importance of, and create a culture of, process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.
- Demonstrate and actively promote an open and honest working environment to encourage close teamwork and foster knowledge transfer.
Travel (up to 25% dependent upon business needs) domestic and/or international. (post COVID)
- Proactively communicate objectives and results with clients, leadership team and all functional partners.
- Undertake all required tasks to meet departmental and project goals and manage and lead various departmental initiatives as required.
- Represent ICON Regulatory Affairs at conferences, committees, webinars and other suitable opportunities.
- Apply scientific principles and maximize compliance to all aspects of regulatory activities.
Oversee preparation and review of scientific and regulatory documents and communication to Regulatory Authorities, in collaboration with internal and external functional experts
- Conceptualise and draft, or lead, a complete proposal based on a client idea or RFP.
- Be aware of project contracts and terms, be able to review them critically and initiate change orders when needed. Manage the financial control of projects (from contract state to invoicing) and be involved in financial processes within the department
- Acts as scientific thought partner with the client and the project team throughout the project
- Take ownership of final budget, deliverable and project timeline and to deliver the work on time, in a profitable manner.
You will need:
* Significant Regulatory Affairs experience including experience in Pharmaceutical/CRO experience.
* Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail.
* Excellent written and communication skills
* Good written and spoken English.
* Proficient in the use of Microsoft Office.
* Bachelor's degree, or local equivalent, in the sciences, or equivalent experience qualification. Masters' degree or higher in the sciences, preferred.
Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON 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, color, 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 through the form below