Senior Director Global Regulatory Affairs 3091276 I.Html
Job Description
Providing strategic regulatory leadership for radiopharmaceutical clinical development programs, the full-time Senior Director, Global Regulatory Affairs will manage global regulatory strategies, oversee major submissions, and engage with health authorities in a remote work environment.
##### Key responsibilities
Develop and execute global regulatory strategies for clinical development and commercial launches
Lead and coordinate major global regulatory submissions, ensuring compliance and strategic alignment
Engage with global health authorities to foster constructive regulatory relationships and ensure consistent messaging
##### Required qualifications
Bachelor's degree in a scientific or life sciences discipline; advanced degree (M.S. or Ph.D.) preferred
Minimum of 10 years of progressive Regulatory Affairs experience in oncology or complex modalities
Proven track record of leading global regulatory submissions and approvals, including INDs and marketing applications
Extensive experience engaging with global health authorities, particularly in oncology development
Strong understanding of global regulatory requirements applicable to oncology and complex therapeutic modalities
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