Welcome to the Arex regulatory affairs team. Our specialists have vast experience in regulatory activities, from development to commercialisation, for pharma, biotech and medtech.
Erik Hedner
Founding Partner
Head of Regulatory Affairs & CMC
MBA, PhD in Medicinal Chemistry
Erik Hedner
Founding partner
Head of Regulatory Affairs & CMC
MBA, PhD in Medicinal Chemistry
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.
Lovisa Rosenquist
Founding partner
COO
BSc Mol Cell Biol
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).
Nelly Fransén
Partner
Head of Development & QA
PhD in Pharmaceutical Sciences
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. Nelly is based in Lund, Sweden.
Catarina Edfjäll
Senior Advisor
PhD in Biochemistry
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. Catarina is a subcontractor to Arex based in Basel, Switzerland.
Alice Olsson
MSc Pharm
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.
Alina Makedonska
MSc Industrial Biotechnology
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. She is based in Lund, Sweden.
Amra Mekic
BSc Pharm
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.
Azadeh Khoshegir
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.
Callum Kitson-Parker
MChem Medicinal Chemistry
Callum is a medical device specialist with over 8 years of experience working within MedTech and pharma, specifically within quality, regulatory, and product development.
He is experienced in developing quality and regulatory strategy, establishing compliant QMSs and leading ISO certification processes, acting as both PRRC and Management Representative in his previous roles. He also manages outsourced medical device development and manufacturing projects, regulatory submissions, and product registrations. Callum is a graduate of the University of Leeds. Callum is based in Lund, Sweden.
Eva Dahlin
MSc Pharm
Eva Dahlin is a specialist in strategic and operational regulatory affairs. She is experienced in launch management, regulatory project and lifecycle management, as well as other functions essential to successful commercialisation in the Nordics and in other European regions. Eva has for over 15 years held leading roles in small to large pharma companies such as Alexion, Mylan (now Viatris) and CSL Behring. Her degree is from Uppsala University.
Isak Simón
MSc Pharm
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.
Josefin Jönsson
Partner
MSc Pharm
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.
Josephine Ingemarsson
Partner
MSc Pharm
Josephine is a regulatory affairs professional specialising in regulatory lifecycle management, both on a global and on a local level. Beside that she has strong experience in conducting complete user readability tests and running serialization projects. She previously worked at ProPharma Group, Sofus Regulatory Affairs and Kronans Apotek, with degrees in Pharmacy from Uppsala University and Sydney University.
Juho Bah
Partner
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.
Kristin Augustsson
MSc Pharm
Kristin is an experienced professional on our regulatory team, specialising in regulatory lifecycle management across the Nordic markets. She has successfully managed post-marketing activities, including product information updates, artwork reviews, market launches and variation submissions. Kristin is also experienced in promotional materials reviews and pharmacovigilance. She has a degree from Uppsala University and has previously worked at Lif.
Maria Flärd
Licentiate, Analytical Chemistry
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. Her latest position was at Prevas, and her degree in Analytical Chemistry comes from Lund University. Maria is based in Lund, Sweden.
Martina Johannesson
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. Martina is based in Lund, Sweden.
Michelle Co
Partner
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.
Olle Fahleson
Partner
MSc Bioentrepreneurship
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.
Rolf Eriksson
Partner
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.
Tove Leire
Partner
MSc Pharm
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. Tove is based in Gothenburg, Sweden.
Unnur Sverrisdottir
MSc Pharm
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.
Staffan Thunell
Founding partner
BSc Economics and BA
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.
