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In the role as _Global Head of Regulatory Affairs_, you lead a global organization of approximately 80 regulatory professionals across CMC Regulatory and Regulatory Affairs and drive regulatory strategies for the established product portfolio, focusing on product integration, lifecycle management,...

Align RegCMC DP strategy for Formycon's development projects and approved products (focus on aseptically manufactured parenteral products in various dosage forms) with project management, DP, device & packaging development departments and other RegCMC groups (DS and Analytics)...

Providing strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior...

• Develop and execute regulatory strategies for products and services
• Provide regulatory expertise for complex or unique issues and challenges regarding registration and compliance activities.

• Author and revise Standard Operating Procedures (SOPs) and quality system documentation in line with ISO 13485 and EU MDR 2017/745 requirements.
• Conduct GAP analyses of the QMS to identify compliance gaps and support continuous improvement activities.