Related skills
cross-functional coordination regulatory affairs gxp ich guidelines regulatory compliance📋 Description
- Lead planning, execution, and tracking for NDA/MAA submissions
- Define scope, goals, and deliverables for programs
- Develop plans, schedules, budgets, and tracking tools
- Monitor progress and adjust plans across functions
- Coordinate cross-functional teams and stakeholder updates
- Ensure timely governance and submission readiness
🎯 Requirements
- Bachelor's degree in Pharmacy, Chemistry, Biology, or related field
- 5 years PM experience in pharma/biotech industries
- GxP and ICH guidelines knowledge; FDA/EMA submissions
- Direct experience with registration-phase programs
- CRO management and global team coordination
- Strong leadership, organizational, and communication skills
🎁 Benefits
- Direct sponsor role within a global CRO
- Career development and growth opportunities
- Collaborative, cross-functional environment
- Global operations across regions
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