Regulatory Affairs Specialist
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
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 organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization 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.
The Role:
Management of activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities for the assigned country/countries.
Management of central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the LRAA is responsible for.
Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
Management of the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA and Central IEC as appropriate.
Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.
Perform role of Local Reviewer in the QC process as appropriate.
Providing consultancy to the client on any country specific issues if requested by the Start-Up Lead (SUL), GRAL, Clinical Team Manager (CTM) or Project Manager (PM).
Supporting the senior level Regulatory staff/Country Consultant in the maintenance of the accurate, up to date Country Knowledge Repository.
Attending internal and external project team meetings as determined by the GRAL, SUL, CTM or PM.
If applicable for the Country, submit expendable safety reports to RAs and central IECs in accordance with relevant legislation and the project-specific contractual agreement.
Any other duties deemed necessary to secure the success of PRA’s business.
Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs.
Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that tools such as the Country
Knowledge Repository and the Country Fact Sheets are up to date; communicate new information or changes to the
Regulatory Intelligence Consultant team.
May work with GRA team members to provide Regulatory consulting services.
May support, prepare and review GMP and product (drug products, medical devices, cosmetics, food, supplement) submissions for product registration and maintenance to Regulatory Agencies with appropriate oversight, supports labeling (leaflet, primary and secondary packaging) and promotional material activities based on relevant regulations and updates regulatory systems accordingly.
To be successful in the role, you will have:
University education in the related field
Fluent English and Hebrew
Experience in the Regulatory Affairs area gained in the clinical research or pharmaceuticals sector
Very good communication and interpersonal skills
Ability to understand country specific requirements and how they need to be applied to a clinical trial or product registration
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.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here
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.
Are you a current ICON Employee? Please click here to apply
