Parexel
Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions
10,000+
💰 Venture Round on 1990-01
Regulatory Affairs Project Manager
4 days ago
Parexel
Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions
10,000+
💰 Venture Round on 1990-01
Description
• Provide comprehensive leadership for regulatory submission projects. • Manage project budgets, resources, and timelines. • Monitor and share industry changes by participating in Health Authorities webinars and workshops. • Ensure high-quality regulatory submission publishing activities. • Conduct project status analysis to assess client needs. • Plan and manage global resources for regulatory submission projects. • Network within the industry to inform management of potential new business leads.
Requirements
• Proven experience in regulatory submission project leadership. • Strong knowledge of regulatory submission processes and eCTD requirements. • Excellent project management skills, including budget and resource management. • Outstanding communication and leadership abilities. • Ability to work effectively with global teams and clients. • Proactive approach to process improvement and industry knowledge sharing. • Experience with safety reporting coordination is a plus.
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