Tarja Ovaskainen has worked at Medfiles since 2012 as a Regulatory Affairs Expert, focusing on new marketing authorisations and the lifecycle management of existing ones. She has also worked as a Responsible Person and reviewed marketing materials over the years.
Tarja holds a Master of Science degree in Pharmacy and graduated in 1997. Prior to joining Medfiles, she gained valuable experience at another consultancy firm, as well as at domestic and international pharmaceutical companies. Her background in regulatory authority work and pharmacy practice has also laid a strong foundation for her regulatory affairs expertise.
Challenging marketing authorisation applications keep the work rewarding
Tarja’s daily work involves a wide range of regulatory tasks for human medicines – including new marketing authorisation applications, variations and notifications, as well as assignments related to distribution products. Her responsibilities include compiling applications, updating regulatory databases, reviewing packaging materials, and closely collaborating with subject matter experts, local contacts and authorities. She also manages project timelines and searches information from authorities’ regulatory guidelines.
Tarja specialises in new marketing authorisations, an area she first became familiar with at the Finnish Medicines Agency (formerly National Agency for Medicines) in 1998, where she coordinated national and mutual recognition procedures. Since then, she has worked with new MAs in various roles across the pharmaceutical industry and consultancy sector.
“New marketing authorisations enable me to utilise my full range of skills and problem-solving abilities. They’re challenging, which is exactly what makes them so motivating.”
Skilled colleagues and varied workdays
What Tarja values most at Medfiles is the diversity of regulatory work and the opportunity to stay up to date with changing regulatory requirements.
“The work changes from day to day and week to week, which adds variety and keeps things interesting. I also truly appreciate the expertise of my colleagues – we have a very professional team.”
Medfiles’ highly qualified team of experts has on average more than 10 years of experience in marketing authorisations and pharmacovigilance working both for the pharmaceutical industry and at the regulatory authorities. By partnering with us, you gain access to customised services tailored to your specific needs. We can take care of the entire marketing authorisation application process (DCP/MRP/CP/NP) for you, in any EU country, from registration strategy to marketing authorisation. You can also outsource only parts of your process to us.
Free Guide: WHAT YOU NEED TO KNOW ABOUT ACTIVE SUBSTANCE REGISTRATION STRATEGY?
Drug substance quality must be demonstrated in the marketing authorisation application, and in Europe, there are three different ways to do this. The choice depends mainly on the API in question. The easiest way is to go with CEP whenever possible.
We have created a guide on the basic information you need to know about registration, so that you can make the best choices for your project.
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