Regulatory and Start Up Manager
On-siteRiyadh, Riyadh Region, Saudi Arabia
Job Summary
Oversee site activation and maintenance for multi-protocol programs, managing pre-award activities, budgets, and resources while resolving project issues. Develop and maintain management plans aligned with scope of work, ensuring collaboration across regions and countries to deliver projects in compliance with regulatory strategies. Provide specialist regulatory and technical scientific support for clinical trial initiation and maintenance, determining submission parameters and offering creative solutions for regulatory complexities. Assess the regulatory landscape to gather and disseminate intelligence, execute operational strategies for study approvals, and negotiate essential contracts. Mentor colleagues, maintain internal systems and project plans, and deliver presentations to clients and professional bodies.
Required Qualifications
- Bachelor's Degree Life sciences or related field
- 7 years' relevant experience in a scientific or clinical environment including demonstrable experience in an international role
- Thorough understanding of regulated clinical trial environment
- In-depth knowledge of drug development process
- Good regulatory and/or technical writing skills
- Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
- Arabic language fluency
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