Mónica Unger-Bady

Expert for regulatory compliance

CONELIS expert Mónica Unger-Bady

Managing Director, Unger-Bady Consulting & Services

Berlin

German, English

Services offered within Europe

www.unger-bady.de

Contact Me

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Call me: +49 (0)30 20275770

Services

 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/)

About me

My strategy is based on…

  • … a high level of competence from considerable hands-on experience.
  • ...  extensive knowledge of the regulatory and product supply environment in an international pharmaceutical company.
  • … commitment to straightforward and highly efficient workflows.
  • … satisfying the employees within your organization.
  • … dedication to regulatory compliance.

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.

Qualifications

Background

  • Pharmacist
  • Expert in Regulatory Compliance
  • Systemic Interactive Coach

Areas of Expertise

  • CMC
  • Regulatory Affairs
  • Interdisciplinary overview

Success stories