Regulatory Submissions Manager
ICON Strategic Solutions
Job Overview
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Job Description
About the Regulatory Submissions Manager Role at ICON Strategic Solutions
ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment driving innovation and excellence. Join our mission to shape the future of clinical development.
What You Will Be Doing
As the Regulatory Submissions Manager, you will lead regulatory activities and submissions independently. You will provide regulatory guidance and operational support across various drug development stages including early development, agency interactions, clinical trial applications and marketing applications, as well as post-approval activities.
- Lead regulatory activities such as CTA, IND, and MAA submissions.
- Offer guidance to internal teams and engage in agency interactions.
- Develop best practices and ensure adherence to global regulatory requirements.
- Collaborate with cross-functional teams on various projects.
- Oversee preparation of core regulatory packs for Canada.
Your Profile
The ideal candidate holds a Bachelor's degree in a scientific or healthcare-related field (advanced preferred) and a minimum of 6 years of experience in regulatory affairs. Experience in regulatory submissions (CTA/IND/MAA) and a strong understanding of global regulatory guidelines are essential. Experience in Companion diagnostics, IVDR submissions, and clinical performance studies is an advantage.
What ICON Can Offer You
ICON values talent and rewards high performance. In addition to a competitive salary, you will enjoy benefits such as annual leave, diverse health insurance options, competitive retirement planning, global assistance programs, life assurance, and flexible country-specific benefits.
Inclusive Culture
At ICON, inclusion and belonging are fundamental. We provide an inclusive, accessible employment environment free from discrimination. If accommodations are needed during the application process, please let us know.
Key skills/competency
- Regulatory Affairs
- CTA
- IND
- MAA
- Global Regulations
- Agency Interactions
- Team Leadership
- Canada Regulations
- Companion Diagnostics
- IVDR
How to Get Hired at ICON Strategic Solutions
- Customize your resume: Highlight regulatory affairs experience and submission expertise.
- Research ICON Strategic Solutions: Understand their innovative clinical research culture.
- Showcase global exposure: Emphasize international regulatory compliance skills.
- Prepare for technical interviews: Review guidelines for CTA, IND, and MAA.
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