About Us

Background

Dr. Mónica Unger-Bady is the founder of Unger-Bady Consulting & Services.

She graduated as a pharmacist specializing in the development, production and quality testing of liposomes.
In 1988 she joined Schering AG, Regulatory Affairs. Here she fundamentally developed the newly designed function of a Regulatory Manager within the Strategic Business Unit for Dermatology.
In 1996 she was appointed to the project Production Strategy Europe, where she developed the regulatory strategy for the crossover site change of multiple European production sites. She successfully supported the company to reorganize their international landscape of production sites thus providing the basis for the new worldwide product supply.
In 1999 she successfully projected, designed and implemented Schering’s regulatory database. She established, maintained and trained standards worldwide to achieve high quality regulatory data thereby preparing an optimal basis for regulatory compliance.
In 2000 she was appointed Head of Variation Management and Compliance. She built up a best-in-class team with high competence in setting and maintaining standards for Regulatory Affairs functions and logistical functions of the product supply chain worldwide. She promoted regulatory workflows into an operational position within the product supply chain. She successfully established processes to achieve, maintain and improve regulatory compliance. Within her department approximately 16 000 variations per year were handled at a worldwide level, providing the company with a sound risk defence.
In 2007 Mónica Unger-Bady decided to start her own business and became an independent consultant in regulatory compliance. Wherever required, Unger-Bady Consulting & Services will provide practical experience and full support for regulatory compliance.
In 2008 Dr. Mónica Unger-Bady graduated as a systemic interactive coach. This has enhanced her competence in providing individual management coaching, including aspects of leadership, reflection on workflows and organizational models, and team-leading.


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					About Us Background Dr. Mónica Unger-Bady is the founder of Unger-Bady Consulting & Services. She graduated as a pharmacist specializing in the development, production and quality testing of liposomes. In 1988 she joined Schering AG, Regulatory Affairs. Here she fundamentally developed the newly designed function of a Regulatory Manager within the Strategic Business Unit for Dermatology. In 1996 she was appointed to the project Production Strategy Europe, where she developed the regulatory strategy for the crossover site change of multiple European production sites. She successfully supported the company to reorganize their international landscape of production sites thus providing the basis for the new worldwide product supply. In 1999 she successfully projected, designed and implemented Schering’s regulatory database. She established, maintained and trained standards worldwide to achieve high quality regulatory data thereby preparing an optimal basis for regulatory compliance. In 2000 she was appointed Head of Variation Management and Compliance. She built up a best-in-class team with high competence in setting and maintaining standards for Regulatory Affairs functions and logistical functions of the product supply chain worldwide. She promoted regulatory workflows into an operational position within the product supply chain. She successfully established processes to achieve, maintain and improve regulatory compliance. Within her department approximately 16 000 variations per year were handled at a worldwide level, providing the company with a sound risk defence. In 2007 Mónica Unger-Bady decided to start her own business and became an independent consultant in regulatory compliance. Wherever required, Unger-Bady Consulting & Services will provide practical experience and full support for regulatory compliance. In 2008 Dr. Mónica Unger-Bady graduated as a systemic interactive coach. This has enhanced her competence in providing individual management coaching, including aspects of leadership, reflection on workflows and organizational models, and team-leading. back to about us

About Us

Background

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