Regulatory Affairs Manager - Remote - Poland, Bulgaria or United Kingdom
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 Regulatory Project Manager (RPM) to join our diverse and dynamic Regulatory Project Services (RPS) team. As an RPM at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Consulting Solutions (RCS) team. You'll provide Project Management and regulatory support across various stages of the project lifecycle, including early/late development, agency interactions, initial and marketing applications, and post-approval activities.
What you will be doing:
* Lead client engagements and interactions, developing professional internal and external communications.
* Lead regulatory activities and submissions, with prior experience in areas such as CTA/IND/NDA/MAA/Post Marketing and Life Cycle.
* Provide regulatory coordination and support to internal teams.
* Manage agency interactions and regulatory submissions by developing detailed timelines and convening appropriate resources.
* Manage projects to remain within budget and scope, while creating detailed plans to support the execution activities.
* Contribute to developing best practices within ICON RPS through your insight of regulatory processes and guidelines.
* Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature.
Your profile:
* Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
* Minimum of 6 years of experience in regulatory affairs or project management within the pharmaceutical or biotechnology industry.
* Prior experience with various regulatory submissions, including CTA/IND/NDA/MAA/Post Marketing and Life Cycle.
* Ability to lead internal teams to execute upon regulatory strategy and client goals.
* Strong understanding of global regulatory requirements and guidelines.
* Understanding of eCTD structure and high-level global publishing approaches.
* Experience with Project Management tools such as MS Project and OnePager.
* Project Management Professional (PMP) and/or Regulatory Affairs Certification (RAC) or similar accreditation a plus.
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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
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