Fredrik Viklund Email & Phone Number

Stockholm / Uppsala / Södermanland Area, Sweden

Freelance consultant with extensive experience in regulatory affairs, cmc documentation and medical writing. Expert leader of authoring teams using lean methods. Focus on performance, professionality and personal relations.Experience include: 2023-2024 Veeva RIM - migration of complex legacy regulatory data and documents to Veeva Vault RIM, acted as a regulatory affairs SME in configuration and implementation of Veeva RIM to support and develop business processes. Bridged the gap between IT/system providers and regulatory affairs.2019-2023 Global regulatory affairs - responsibilities included registration in new markets, variations in CMC and clinical for both biotech products and chemical entities.2018-2019 Dossier management, CMC authoring and change management for biotech products at a leading company in rare diseases.2015-2018 Regulatory affairs manager at the Swedish branch of a major pharmaceutical company. Regulatory responsibility for OTC/Rx medicines and medical devices, including assessment of marketing materials for some of the best known brands on the market.

Strängnäs

I lead the board of Strängnäs Montessori which is a parent owned, not for profit school and preschool based on the Montessori pedagogy with a staff of around 90 who teach and care around 450 children.

Authoring and coordination of Chemistry, Manufacturing and Control (CMC) regulatory documentation for global variations and other regulatory applications.

Authoring and team lead for clinical study reports, IB:s, clinical overviews and clinical summaries used in regulatory applications.

Authoring and team lead for clinical study reports and other regulatory documents used in clinical development.

Stockholm

Development of legislation concerning waste handling and treatment. Evaluation of the environmental effects of legislation and policies in relation to national goals.

Stockholm

Scanning, transcription, editing and adapting printed books to electronic formats suitable for reading impaired students.

Dept Of Biotechnology, Biocatalysis Group

I developed synthetic methods for surfactants that are extremely hard to produce with traditional chemistry. Cooperation with AstraZeneca AB (pharmaceutical applications), Karlshamns AB (food) and Polymer Technology (KTH). Apart from scientific publications the project also resulted in an international patent.

Dept Of Biotechnology, Environmental Microbiology

A UNICEF-financed project to develop cheap and robust methods for determination of bacteria and parasite eggs in composts and soil. The methods were tested on the field in Central America and Asia.