Pharma Regulatory Affairs Team Leaders

Heta Karvinen
Director, Pharma Regulatory Affairs

Heta Karvinen has worked at Medfiles since 2013. All in all, she has some 15 years of experience from pharmaceutical development, marketing application dossiers and post-approval changes. Before joining Medfiles, Heta was involved in drug product and drug substance development in the pharmaceutical industry.

She has experience from planning pharmaceutical and chemical studies needed for global marketing authorisation applications as well as the regulatory guidelines that govern such studies. Previously at Medfiles, Heta worked as a senior pharmaceutical chemical expert, utilising her skillset in various drug development projects as well as managing quality dossiers for human and veterinary medicines, post-approval variation applications and the studies required to support them. During the years, she has gained valuable expertise from active substance documentation in both the European Union and the United States. In February 2022, Heta was appointed Director of Pharma Regulatory Affairs at Medfiles.

Anna Alonen
Head of Operations, Pharma Regulatory Strategy

Anna Alonen joined Medfiles in 2014. As the leader of a team of marketing authorisation experts, Anna’s responsibilities encompass new marketing authorisation applications and regulatory strategies. Anna and her team are experienced in working with regulations.

Medfiles’ marketing authorisation experts have helped clients to plan regulatory strategies, successfully compiled marketing authorisation applications and coordinated application procedures.

Anna’s journey at Medfiles began as a marketing authorisation expert, a position in which she honed her skills and knowledge of the field. Armed with a Ph.D. in pharmaceutical chemistry, acquired during her tenure at the University of Helsinki, Anna brings with her a strong, academic educational background. Her past engagements at the Finnish Medicines Agency and Pharma Industry Finland have further enriched her expertise, equipping her with valuable insights into the broader pharmaceutical landscape. Anna’s wide-ranging skill set covers research, expert consultancy, team management and project leadership.

Ulla Orava
Head of Operations, CMC

Ulla Orava has worked at Medfiles since 2007. She has more than 20 years of experience from pharmaceutical development, product maintenance, marketing authorisation dossiers and post-approval variations. Before joining Medfiles, Ulla worked with assessment and coordination of variations at the Finnish Medicines Agency, as well as with drug product development and product maintenance in the pharmaceutical industry.

She has experience from planning pharmaceutical and chemical studies needed for global marketing authorisation applications as well as the guidelines steering these studies. In addition, Ulla has considerable competence in changes needed for drug products, problem solving, planning and classification of variations and writing variation documentation, not to forget a good grasp of how the authorities interpret variation guidelines. At Medfiles, Ulla’s roles as Head of CMC Operations, leading an extremely experienced team of CMC experts, and before that, as a CMC Expert, have allowed her to fully utilise her wide range of expertise in various drug development projects and in managing the quality dossiers for human and veterinary products and post-approval variation applications.

Mikko Reinman
Head of Operations, Pharma Regulatory Affairs

Mikko Reinman has worked at Medfiles since 2009. Biochemist and food chemist by education, Mikko has extensive laboratory experience, having worked as an R&D chemist and analytical chemist in several companies. During his career, Mikko has been involved in various pursuits, including developing analytical platforms and targeting technologies, as well as quality assurance and IPR issues.

After switching to pharma regulatory, Mikko has gained more than 15 years of experience in product maintenance, first at a pharma company and then at Medfiles. Mikko’s first position in the pharma regulatory field involved working with product information texts and local regulatory responsibilities, and later, he proceeded to global regulatory manager tasks, including marketing authorisation maintenance and variation strategies. At Medfiles, Mikko has also worked with pharmacovigilance, compliance, project management and marketing. Since 2014, Mikko has worked as a regulatory affairs manager, and today, his title is Head of Operations, leading a team of highly skilled regulatory experts.