For example timely execution of the regulatory plans and other regulatory activities for existing and new products, supporting project teams during product development, writing and developing regulatory plans, coordinating activities with other stakeholders, reviewing, preparing and following up regulatory files, submissions to Authorities, management of the existing licenses.

I have built up well functioning organisations with good results in Nordic-, Benelux-countries as well as in Poland. Created regional teams that has facilitated and created better result and cooperation between the countries. During > 30 years engagement in Pharma business I have developed very good relation with regulators at Competent Authorities in the specific countries. Been closely involved in strategic planning with regulatory intelligence.

I have been responsible for developing and implementing Quality Management System in these affiliates based on SOPs/WI/Encl, including writing SOP´s etc, training of staff and executed management reviews with leadership teams. Developed and implemented Dawn Raid guidelines.

In 20 years I have been responsible for a Wholesales dealer´s license in Sweden.

Since my very long engagement within the Pharmaceutical industry, I have also knowledge and experience within pricing and reimbursement, medical information, patents and trademarks.

My leading words are clarity, competence and passion with them I guide myself and others through the tasks to finalization.