Founding partner, CEO
During her 25 years in the pharmaceutical industry Linda has held various executive positions, and between 2002 and 2019 she was the founder and CEO of Sofus Regulatory Affairs AB. She has also worked as Head of Regulatory Affairs in pharma companies and as assessor at the Swedish Medical Products Agency.
BSc Economics and BA
Founding partner, CFO
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.
PhD Med Chem and MBA
Founding Partner, Director Drug Development
Erik specialises in areas related to drug development and regulatory CMC. After a PhD in Medicinal Chemistry he worked as a CMC assessor at the Swedish Medicinal Products Agency. He has since held various expert positions within pharma consulting, primarily with a focus on CMC in phase I-III projects.
BSc Mol Cell Biol
Founding partner, Director Post-Marketing Projects
Lovisa is a senior regulatory project manager with extensive experience from leading positions at consultancies, managing Nordic as well as global projects. She specialises in assisting companies with market entry and product launch activities. Lovisa started her career at the European Medicines Agency (EMA).
MSc Health Economics
Partner, Head of Market Access
Susanne specializes in strategic market access and HTA. Her expertise includes strategic landscape assessments, development of reimbursement dossiers and stakeholder interactions. She has experience as project manager for a variety of strategic market access projects, from phase II to post-marketing. She has previously worked at a global consultancy firm.
PhD in Neurochemistry and Neurotoxicology
Partner, Quality Manager
Katarina specialises in quality assurance and pharmacovigilance. She has specific experience in quality management systems, both for GDP and for pharmacovigilance work. Katarina has held the position of Responsible Person for many years and has experience from inspections by most of the Nordic Competent Authorities for medicine. She holds a PhD in Neurochemistry and Neurotoxicology from Stockholm University.
Kristin is on our regulatory and pharmacovigilance team. She is a pharmacist graduated from Uppsala University who brings with her experience from working at the Swedish Association of the Pharmaceutical Industry (LIF). There she reviewed data on medicines published on FASS.se and assisted with analyzing clinical trials data for covid-19 vaccines.
PhD in Organic Chemistry
Juho is a senior professional in regulatory affairs. Working at the intersection of CMC, quality assurance and regulatory, he maintains a focus on global regulatory projects, technology transfers and life-cycle management. After obtaining a PhD in Organic Chemistry from KTH, he worked in companies of varied sizes and therapeutic profiles, taking on various regulatory responsibilities during pharmaceutical product development.
Tamara is a specialist in regulatory affairs CMC and QA. She has, in addition to several years in regulatory CMC, a broad experience of lifecycle management, stakeholder management, deviation management, change management and GMP compliance. Before joining Arex she was with AstraZeneca. Tamara's MSc degree in Pharmacy comes from Uppsala University.
BSc Business and Economics
Linnea is our Finance Assistant. She has a BSc in Business and Economics from Södertorns University and has previously worked in the accounts payable department at Huddinge Kommun.
PhD in Analytical Chemistry
Michelle specialises in areas related to drug development, regulatory CMC and QA. She provides regulatory strategies, compiles Module 3 documents, writes risk assessments and reviews analytical method transfer processes. With a background in chemical engineering and a PhD in Analytical Chemistry, Michelle has worked as a CMC assessor at the Swedish Medical Products Agency and as an expert in a quality working group at the EMA.
PhD in Biochemistry
Based in Basel, Switzerland
Catarina has more than 25 years' experience in global regulatory affairs and regulatory intelligence. She has held leadership roles within CSL Behring, Roche, Celgene (now BMS) and other international pharma and biotech companies. She has been responsible for the marketing authorization of over 20 innovative products and new indications (including for orphan drugs), reorganized global regulatory affairs departments and led successful health authority negotiations.
PhD in Biomedicine
Rolf specializes in global regulatory affairs and regulatory CMC. He holds a PhD in Biomedicine and came to us from a position as Regulatory Affairs Director at Rare Thyroid Therapeutics. Prior to that he was a Managing Consultant, Director and Partner at Sofus Regulatory Affairs AB. Rolf has also worked as Regulatory Affairs Officer at Orion Pharma.
Olle specializes in regulatory affairs and CMC. He has been working with various European and global markets, gaining experience in regulatory project management and submissions for pre- and post-marketing phases of the product life-cycle. Olle is also experienced with ethical review of promotional materials within the Nordics. After obtaining a Master’s degree in Bioentrepreneurship at the Karolinska Institute, he worked at a global pharmaceutical company as a regulatory CMC manager.
Anastasia is Marketing Manager with over 12 years of experience in marketing and business development within life sciences. She worked for hearing implant manufacturer Cochlear; following that, she was with IPSEN AB. She holds a PhD in Linguistics and a BA in Finance.
Licentiate, Analytical Chemistry
Based in Lund, Sweden
Maria is a senior specialist in in drug development with over 25 years of experience from quality assurance and regulatory affairs for biologics, specifically oncology and monoclonal antibodies. At Arex Maria will enhance our CMC and quality assurance side with skills in setting up drug development programs and quality systems, as well as managing regulatory submissions and preclinical/clinical studies. Maria’s latest position was at Prevas, and her degree in Analytical Chemistry comes from Lund University.
PhD in Pharmaceutical Sciences
Based in Lund, Sweden
Nelly specialises in formulation development, regulatory CMC and quality assurance. Her expertise includes formulation technologies and drug absorption from development to tech transfer, scale up and production support. Nelly supports our clients with expert advice on CMC documentation, regulatory strategies, product and process improvements, QA assignments within both GDP and GMP such as QMS set-up, acting responsible person, qualified person or performing audits. She is a Pharmacist with a Doctorate in Pharmaceutical Sciences from Uppsala University, and has previously worked as Director R&D and Responsible Person GDP in a smaller pharmaceutical company.
Based in Lund, Sweden
Viola specializes in quality assurance, focusing on Good Distribution Practice (GDP) and Good Automated Manufacturing Practice (GAMP). Viola assists our clients with wholesaler distribution authorization applications and computerized system implementation, taking on the role as Responsible Person GDP and other quality assurance tasks. She is a Pharmacist educated at Uppsala University and the University of Navarra. She previously worked with Quality Assurance at Teva Sweden.
PhD Medical Science
Martina specializes in drug development, with over 20 years of experience in cell therapy from early pre-clinical to clinical phase. She focuses on regulatory affairs, project management, and medical writing in drug development - all with an emphasis on ATMP (Advanced Therapy Medicinal Products). Her most recent role was Cell Therapy Program Manager at Idogen. She holds a PhD in human embryonic stem cell research and an MSc in Molecular Biology from Lund University.
Josefin specializes in regulatory CMC and global regulatory affairs. She has extensive experience of working with pharmaceutical companies, focusing on coordination of CMC documentation for EU and US submissions from Phase I to new drug applications and life cycle management. Josefin started her career at the Swedish Medical Products Agency, and worked on early-phase projects at Fresenius Kabi.
MSc Pharmaceutical Sciences
Melissa joins our regulatory affairs team, where her role will include working with local regulatory affairs for the Nordic markets and with medical information. She is an experienced pharmacist with a degree from Uppsala University and a history of working for some of Sweden’s largest pharmaceutical chains, such as Apotek Hjärtat and Kronans Apotek.
Sozyar works with pharmacovigilance and quality assurance. In parallel with her studies at Uppsala University she worked with GMP processes at Svensk Dos AB. Sozyar did her Master’s Thesis at the Swedish Medical Products Agency.
BSc Biomedical Science
Azadeh specializes in regulatory CMC, with a strong background in global projects within big pharma. Her experience includes managing life-cycle submissions of variations, renewals, US Annual Reports, MAAs, and responses to health authority queries. She also has solid experience in quality supplier management. Azadeh most recently worked at AstraZeneca. She received her degree from Umeå University.
MSc Media & Communication
Ann is a professional in branding and communication with strong experience of leading teams and developing effective strategies. Most recently she worked as Client Service Director at the global agency Up There, Everywhere. She is a graduate of Uppsala University.
Based in Gothenburg, Sweden
Tove is a regulatory affairs professional specialising in regulatory lifecycle management. She has broad experience covering all aspects of post-approval activities, such as product information handling, artwork creation, market launch and variation submissions on the Nordic market. She is also experienced with reviewing promotional materials and writing SOP's and Work Instructions for the regulatory area. She has an MSc in Pharmacy from Uppsala University, and has worked at ProPharma Group, Sofus Regulatory Affairs and LIF.
MSc Medical Biotechnology
Ellinor is a regulatory affairs expert with a strong focus on global projects in Regulatory CMC. She has worked with regulatory compliance, regulatory submissions, stakeholder relations and regulatory project management. Ellinor’s Master’s degree comes from KTH in Stockholm, and her most recent role was at AstraZeneca.
Karin Leoson (née Nylander)
Karin is experienced in pharmacovigilance, predominantly from the Nordic markets. Her experience extends from case management to database entering and MedDRA coding, and she is also skilled in quality management systems for pharmacovigilance. Before joining Arex she worked as a Safety Data Management Specialist at Pfizer, and as a Regulatory Affairs and Pharmacovigilance Consultant at ProPharma Group and Sofus Regulatory Affairs.
PhD in Protein Crystallography
Based in Melbourne, Australia
Jacinta is a senior regulatory affairs manager with a focus on global regulatory portfolio management and regulatory CMC. With over a decade of consulting experience for both large and small companies, she has also developed apps and IT tools and used Design Thinking approaches to optimize regulatory department processes.
MSc Industrial Biotechnology
Based in Lund, Sweden
Alina's core experience is in regulatory affairs and CMC, and she has also worked in quality assurance, developing quality systems and preparing sites for GMP inspections. She has been responsible for the successful registration of 10 new marketing authorisations, and has project managed many technology transfer processes. Alina has an MSc in Biotechnology from Kyiv Polytechnic Institute and joined us after working as Head of RA and QA at Movi Health.
Victor is a Medical Doctor with experience in a variety of pharmacovigilance functions: EEA QPPV/LPPV, as well as a drug safety role within clinical trials and marketed products, regulatory affairs, medical writing, as drug safety physician and in PV quality assurance. He was educated at Moscow Medical University and Gothenburg University. Before joining the team he held senior positions at ProPharma Group, TFS Health Science, IRW Consulting, Servier and GlaxoSmithKline.
Amra works in our regulatory and pharmacovigilance teams, and with review of promotional materials. She is a pharmacist from Linneaus University and also has an MA in Communication. She has previously worked as Manager of a health clinic and Pharmacist.
Alice is part of our regulatory affairs team, working with local regulatory affairs for the Nordic markets. She is a pharmacist with a degree from Uppsala University. Prior to joining Arex, Alice worked at Kronans Apotek.
PhD in Medicine
Based in Tampere, Finland
Camilla provides pharmacovigilance and regulatory affairs support to our clients. She has a PhD in Medicine from Umeå University. Her previous work experience includes working as a pharmacist, as well as in a variety of pharmacovigilance functions at Niconovum. Camilla speaks fluent Finnish.
MSc Formulation and Biopharm
Minh is a senior consultant in regulatory affairs and CMC. He has an MSc in Formulation - Pharmatechnology and Biopharmacy, but also in International Strategy and Marketing. He held roles at Galderma and at AstraZeneca, most recently as Global Regulatory CMC Manager.
MSc Chemical Engineering
Pernilla specializes in quality assurance, with experience from both the GMP and the GDP sides of product development and throughout the product life cycle. She has a background from QC and various QA positions, including roles as acting RP and QP. Pernilla received her MSc at Mälardalen University, and joined Arex after previous employment with ProPharma Group and Sofus Regulatory Affairs.
Isak works in regulatory affairs and quality assurance. His main focus is GDP, regulatory lifecycle management and compliance review. Isak joins Arex after a role at ApoEx, where he specialised in the distribution and provision of unlicensed medicines for early access, e.g. on a named patient basis or compassionate use. He has previously worked at the Swedish Medical Products Agency with parallel import and the National Medication List.
Unnur specializes in market access and regulatory affairs. Her primary focus is on market access for the Nordic markets and ethical review of promotional materials. Unnur is from Iceland and received her degree in Pharmaceutical Sciences from the University of Iceland. She previously worked at Teva/Actavis and Alvogen.
BSc Business and Economics
Emelie is our Finance Manager who joined Arex after working at KPMG, where her most recent position was Project Coordinator International Tax. Emelie has also worked as a tax officer at the Swedish Tax Agency and as Head of Tax and Legal at a non-profit organisation.