Senior Global Program Regulatory Manager (m/f/d)
- Provides input to global program regulatory strategy, including innovative approaches
- May lead global regulatory affairs (RA) for specific program aspects
- Coordinates regulatory readiness across functions and regions
- Represents RA in cross-functional activities
- Contributes to core data sheet development and maintenance
- Coordinates Health Authority (HA) interactions
- Leads planning and submission of clinical trials
- Implements global registration strategy into regional submissions
- Ensures timely compliance reports submission
- Manages life cycle activities, including portfolio transformation and operational excellence
- Science based BS or MS. Advanced degree (e.g., MD, PhD, PharmD, regulatory) preferred
- Advanced understanding of pharmaceutical development, clinical trials, analysis and interpretation of scientific data
- Awareness of post-marketing/brand optimization strategies and commercial aspects
- Multiple years involvement in regulatory and pharmaceutical development spanning activities in Phases I-IV in 1 or more major region
- Experience in leading cross-functional teams
- Strong collaboration, communication influencing and problem solving skills
- Organizational awareness (e.g., interrelationship of departments, business priorities)
- Compliance and Quality mindset
- Languages: Fluency in English both written and spoken is requirement as a business language. Additional language is an asset
- Must be located in GMT+1 zone
- Very Renowned Pharmaceutical Company
- International Environmen
- Ability to work Fully Remote
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