Director, Global Regulatory Affairs Operations Project Manager

Employer Industry: Biotechnology

• Salary up to $
• Opportunity for career advancement and growth within a leading biotechnology company
• Comprehensive health benefits including medical, dental, and vision insurance
• Generous time off policies including paid vacation, sick leave, and parental leave
• Support resources for family care, financial wellness, and emotional well‑being
• Flexible work environment with the possibility of remote work

• Partner with the Global Regulatory Lead to ensure effective execution of global regulatory project plans
• Lead cross‑functional submission working groups to deliver successful submissions to Health Authorities
• Develop and maintain regulatory milestone trackers and project plans for assigned programs
• Prepare reports on regulatory milestones and collaborate with stakeholders on operational strategies
• Drive continuous improvement by identifying and proposing solutions for regulatory processes

• Bachelor's degree required
• Minimum of 12 years of related experience in the pharmaceutical/biotech industry, including 4+ years in Global Regulatory Affairs
• Significant experience in global drug development regulations and regulatory submissions
• Excellent verbal and written communication skills with the ability to prepare effective presentations
• Strong organizational skills with the ability to manage multiple projects within timelines

• Experience with regulatory submissions in multiple markets (e.g., US, EU, JP, ROW)
• Proven leadership in cross‑functional, global team structures
• Familiarity with project management software and tools (e.g., MS Project, SharePoint)
• Ability to travel 4-5 times per year

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