Meet our experts

Regulatory Affairs

With Arex, you have a full suite of expertise at your fingertips. 

Erik Hedner

Founding Partner
Director Drug Development

PhD Med Chem and MBA

Lovisa Rosenquist

Founding partner
Director Post-Marketing Projects

BSc Mol Cell Biol

Alice Olsson

MSc Pharm

Alina Makedonska

Based in Lund, Sweden

 MSc Industrial Biotechnology

Amra Mekic

BSc Pharm

Anna Ravnefjord

Based in Gothenburg, Sweden

MSc Biology

Azadeh Khoshegir

BSc Biomedical Science

Catarina Edfjäll

Senior Advisor
Based in Basel, Switzerland

 PhD in Biochemistry

Ellinor Lindholm

MSc Medical Biotechnology

Eva Dahlin

MSc Pharm

Isak Simón

MSc Pharm

Josefin Jönsson

Partner

MSc Pharm

Josephine Ingemarsson

Partner

MSc Pharm

Juho Bah

PhD in Organic Chemistry

Kristin Augustsson

MSc Pharm

Maria Flärd

Based in Lund, Sweden

Licentiate, Analytical Chemistry

Martina Johannesson

PhD Medical Science

Michelle Co

Partner

PhD in Analytical Chemistry

Minh Pham

MSc Formulation and Biopharm

Nelly Fransén

Partner
Based in Lund, Sweden

 PhD in Pharmaceutical Sciences

Olle Fahleson

Partner

MSc Bioentrepreneurship

Rolf Eriksson

Partner

PhD in Biomedicine

Tamara Behnan

MSc Pharm

Tove Leire

Partner
Based in Gothenburg, Sweden

 MSc Pharm

Unnur Sverrisdottir

MSc Pharm

Erik Hedner

Founding partner
Director Drug Development

PhD Med Chem and MBA

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
Director Post-Marketing Projects

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).

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

Based in Lund, Sweden

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.

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.

Anna Ravnefjord

MSc Biology

Anna Ravnefjord is a senior professional in global regulatory affairs, with deep and long-ranging experience in clinical trials at Phase 1, 2a and 2b; IND applications and interactions with EU and US regulatory authorities. She is highly skilled in marketing authorisation applications and license maintenance activities for both development products and mature brands. Anna has held senior regulatory and research roles at AstraZeneca. She is a published scientist and holds a degree from Gothenburg University.

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.

Catarina Edfjäll

Senior Advisor
Based in Basel, Switzerland

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.

Ellinor Lindholm

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.

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

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 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.

Maria Flärd

Based in Lund, Sweden

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. Maria’s latest position was at Prevas, and her degree in Analytical Chemistry comes from Lund University.

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.

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.

Minh Pham

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.

Nelly Fransén

Partner
Based in Lund, Sweden

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.

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.

Tamara Behnan

MSc Pharm

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.

Tove Leire

Partner
Based in Gothenburg, Sweden

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.

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.