Regulatory Submissions Manager

Regulatory Submissions Manager reputed company 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 Manager, Regulatory Affairs to join our diverse and dynamic team. As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team. You'll provide regulatory guidance and operational support across various stages of drug development, including early development, agency interactions, clinical trial applications, marketing applications, and post-approval staff. What you will be doing

• reputed company regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA
• Provide regulatory guidance and efforts to internal teams
• Participate in agency interactions and regulatory submissions
• Contribute to developing best practices reputed company ICON Regulatory Affairs 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-reputed company field; advanced degree preferred
• Minimum of 6 years of experience in regulatory affairs reputed company the pharmaceutical or biotechNlogy industry
• Prior experience with various regulatory submissions, including CTA/IND/MAA
• Ability to reputed company internal teams and carry out regulatory activities independently
• Strong understanding of global regulatory requirements and guidelines
• Must have experience overseeing preparation of core regulatory packs for Canada
• Experience is Companion diagnostics, IVDR submissions, clinical performance studies is preferred What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a reputed company 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 reputed company 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 reputed company.
• Global Employee Assistance Programme, reputed company, 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 reputed company to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for reputed company candidates. ICON is committed to providing a workplace free of discrimination and harassment. reputed company qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly reputed company’re looking for here at ICON whether it is for this or other roles. Are you a reputed company ICON Employee? Please Apply tot his job

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