Clinical Careers Page

Regulatory Submissions Manager

Clinical Careers Page(13 days ago)

Burlington, Ontario, CanadaOnsiteFull TimeSenior$110,230 - $149,532 (estimated)Regulatory Affairs
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About this role

A Manager, Regulatory Affairs at ICON plays a key role in supporting drug development through regulatory guidance, submissions, and agency interactions. The position involves leading regulatory activities for pharmaceutical and biotech projects, ensuring compliance with global regulatory requirements, and working collaboratively with internal teams and regulatory agencies.

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Required Skills

  • Regulatory Submissions
  • Regulatory Guidance
  • CTA
  • IND
  • MAA
  • Global Regulations
  • Drug Development
  • Cross-functional Collaboration
  • Regulatory Strategy
  • Canada
Clinical Careers Page

About Clinical Careers Page

iconplc.com

ICON plc is a global clinical research organisation (CRO) that provides outsourced clinical development and commercialisation services to pharmaceutical, biotechnology and medical device companies. It offers end-to-end drug and device development support — including clinical trial management across phases, data management and biostatistics, regulatory and safety/pharmacovigilance, and commercialisation and market-access services. ICON combines scientific and therapeutic expertise with technology and a scalable global operations network to accelerate development and bring therapies to patients. Clients engage ICON for integrated, experienced CRO support across the full product lifecycle.

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