Senior Global Regulatory Affairs Specialist

Senior Global Regulatory Affairs Specialist - Warsaw, Poland - Homebased 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. As a Senior Global Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. Responsibilities:

1. Coordinate all Central Independent Ethics Committee (IEC), Regulatory Agency (RA), and other central authority submissions to ensure adherence to contractual timelines.
2. Communicate submission status updates to the Start-Up Lead (SUL) and collaborate to mitigate risks to Sponsor deliverables.
3. Provide the Sponsor and internal Project Team with information on regulations governing the clinical trial at a project level.
4. Address Sponsor queries related to regulatory and submission requirements.
5. Prepare the Core Clinical Trial Application and perform quality control (QC) on the content of all central submission packages.
6. Support Business Development efforts by contributing regulatory input for Requests for Proposal (RFPs), Requests for Information (RFIs), and participation in Bid Defence Meetings.

Your profile:

1. Bachelor's degree in a scientific discipline or related field.
2. Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
3. Strong understanding of global regulatory requirements and guidelines.
4. Excellent communication in English.
5. 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, 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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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. #J-18808-Ljbffr