Dr. Mónica Graciela Unger-Bady
Founder of Unger-Bady Consulting & Services.
I offer my personal practical experience and support to develop straightforward workflows which are feasible for your environment and efficient at solving your problems. My strength lies in focusing on the people doing the work and on supporting the implementation of new workflows with training and individual coaching. My goal is frictionless and well implemented workflows resulting in high-quality results for you. Only feasible and well implemented processes ensure satisfaction and efficiency in the company. My engagement leads to measurable capacity and cost savings.
How I see myself
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.
In 1988 I had graduated as a pharmacist and completed my PhD in the development, production and quality testing of liposomes. I started my career in Regulatory Affairs at Schering AG. Here I was instrumental in developing the newly designed function of Regulatory Manager within the Strategic Business Unit for Dermatology.
In 1996 I was appointed as regulatory head of the project “Production Strategy Europe”. Here I developed the regulatory strategy for the crossover site change of multiple European production sites. I successfully supported the company in reorganizing their international landscape of production sites thus providing the basis for the new worldwide product supply.
In 1999 I successfully projected, designed and implemented Schering’s regulatory database. I established, maintained and trained standards worldwide to achieve high quality regulatory data, thereby preparing an optimal basis for the company’s regulatory compliance.
In 2000 I was appointed “Head of Variation Management and Compliance”. I 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. I promoted regulatory workflows into an operational position within the product supply chain and successfully established processes to achieve, maintain and improve regulatory compliance. Within my department approximately 16 000 variations per year were handled at a worldwide level, providing the company with a sound risk defense.
In 2007 I decided to start my 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 I graduated as a systemic interactive coach. This has enhanced my competence in providing individual management coaching, including aspects of leadership, reflection on workflows and organizational models, and team-leading.