My name is Pavlina Antova and my professional path has been connected with the pharmaceutical industry for years.
To work in this sector means to help people to get better, to feel better, to improve the quality of their lives, and this is the most important thing for me.
I am working at Tchaikapharma for almost 10 years, and for the last 5 years I am involved in the process of registrations of medicinal products for human use. My work is related to obtaining, maintaining and making changes to the authorizations for medicinal products use.
The changes that have taken place in Bulgaria since the country joined the European Union and the harmonization of the Bulgarian legislation with the European legislation have made the regulatory work quite dynamic and interesting.
How does a typical day go for a registrar? This is a difficult question…
What I have planned for the day can easily change. There is no such thing as a ‘typical’ day – every day is different and that is one of the things I enjoy the most about my job. In general, however, the work day consists of phone calls and correspondence with business partners and regulatory officials, writing and reviewing documentation, and organizing and attending meetings.
Much of the work in regulatory involves long-term projects and this enables me to plan my time very well.
The work of a drug registration expert depends heavily on the personal qualities and qualifications but is by no means entirely self-sufficient. Excellent teamwork and constant collaboration with my colleagues in Quality Control, Strategic Development, Procurement and Logistics are also an integral part of our department’s daily routine.
My name is Nikolay Nedyalkov and I am the head of the manufacturing plant in Varna. I graduated Automation and Control Systems at Varna Tech University and since then have gathered 18 years of experience in the pharmaceutical field.
My day starts with an overview of the production facilities, a conversation with the shift manager on the implementation of the production planning, discussing possible technical issues. Together with the staff in the Quality Control Department we discuss the results of the ongoing analyses and identify the measures to be taken.
Together with the Logistics department, we clarify the upcoming deliveries, possible schedule changes and the possibilities to compensate for possible backlogs. We review future orders, their volumes and lead times. I also monitor the supply of packaging materials, plan repairs and purchase spare parts.
After discussing the current situation, I clear up any changes made to the production planning with my immediate superiors in line, including recent supply changes. I then prepare a daily report. Occasionally, I also hold meetings with external suppliers and subcontractors.
In my work, it is extremely important to follow the standards of good manufacturing and distribution practice and to comply with European directives and requirements. On a daily basis, I keep myself informed about the latest news in the pharmaceutical sector and about any international and national regulations and remedies.
