Mónica Unger-Bady

 Practical Experience

• Audit Regulatory Affairs
• Provide practical experience for regulatory compliance
• Develop regulatory strategy for expansive variations

Reliable Data

• Develop and project databases for Regulatory Affairs
• Develop, implement and train workflows to generate high quality regulatory data 

Risk assessment

• Risk-management for regulatory compliance

• Workflows

• Develop and implement workflows, interfaces and standard operation procedures for regulatory compliance
• Mediate between Regulatory Affairs and Production services
• Develop processes for interaction between Regulatory Affairs and Research & Development

Coaching and Training

• Coach executives especially for implementing new workflows
• Provide specifically tailored in-house workshops for regulatory compliance
  (http://en.unger-bady.de/seminars/)

My strategy is based on…

My profile

• Executive manager, consultant and coach for Regulatory Affairs in pharmaceutical industry
• Profound professional knowledge with regard to interdisciplinary and global workflows / organizations especially in Regulatory Affairs and Regulatory Compliance as well as the development and implementation of involved IT-solutions.
• Powerful, stringent and cooperative leadership aligned with conceptional thinking and assertiveness as well as sure instincts for politically correct and perceptive implementation of projects were prerequisites of the current success.

Background

• Pharmacist
• Expert in Regulatory Compliance
• Systemic Interactive Coach

Areas of Expertise

• CMC
• Regulatory Affairs
• Interdisciplinary overview

Auditing Regulatory Affairs

• see http://en.unger-bady.de/success-stories/#1459335413080-e84b62a7-5136

Introducing regulatory compliance

• see http://en.unger-bady.de/success-stories/#1459335413152-91916f06-67a0

Reorganizing regulatory workflows and processes

• see http://en.unger-bady.de/success-stories/#1459335696145-45658f8e-9574

Developing, implementing and maintaining regulatory databases

• see http://en.unger-bady.de/success-stories/#1459335749640-edb068cd-4052

Developing a Research & Development handbook

• see http://en.unger-bady.de/success-stories/#1459335790148-53089001-b60c

Giving seminars and workshops

• see http://en.unger-bady.de/success-stories/#1459335826386-46ca4dc0-0037
• see http://en.unger-bady.de/seminars/