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
We are currently seeking a Senior Global Regulatory Affairs Specialist to join our diverse and dynamic team. The Senior Global Regulatory Affairs Associate fulfills the role of Global Regulatory Affairs Lead (GRAL) and is responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met (except in the United States and Canada, where the GRAL does not coordinate central IRB/IEC submissions).
What you will be doing:
Coordination of Central Independent Ethics Committee (Central IEC), Regulatory Agency (RA) and other central or country level authority submissions to ensure contractual timelines are met.Providing regulatory guidance and support to cross-functional teams throughout the drug development process.
Provide the client and the internal team information on regulations and drug considerations at a project level and answer client questions surrounding these.
Provide submission strategy to the client along with all requirements and documentation requests to actualize proposed strategy.
Managing regulatory submissions and interactions with health authorities.
Preparation of the Core Clinical Trial Application and perform QC on the content of all central submission packages to ensure they meet the needs of the trial protocol, sound scientific and therapeutic area principles and any other study requirements.
Act as GRA partner to support the Country Consultant and complete review of Country Fact Sheets to timelines for assigned country(s).
Provide mentoring and training for more junior roles in team. May be delegated ownership for areas of the Country Knowledge Repository and be responsible for liaising with other operational departments to ensure the database contains accurate Country intelligence.
Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs, including representing GRA at internal and external BD meetings.
Your profile:
Bachelor's degree in a scientific discipline or related field.
Minimum of 5 years of experience in regulatory affairs submissions within the clinical research industry.
Demonstrates complete understanding and application of clinical research regulations, concepts and standards.
Strong understanding of global regulatory requirements and guidelines.
Demonstrates a good understanding of country requirements and how they need to be applied in the clinical trial environment.
Proven history of successful interaction with project teams and a basic understanding of each related function
Excellent communication and social skills.
Ability to work independently and collaboratively in a fast-paced environment.
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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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
