Preclinical and Toxicology Expert (m/f/d)

Founded in 1994, regenold GmbH is today an international consulting and service company with more than 100 employees. We accompany customers worldwide in the development, admission and market access of medicines, food supplements and cosmetics, as well as medical products and in vitro diagnostics. We're looking for you as soon as possible Preclinical and Toxicology Expert (m/w/d) in full time Do you want to work with us? Then we should get to know each other!

Strategic advice on preclinical development of medicines and medical products Assessment and processing of preclinical deviations and inspection and audit results Preparation and technical examination of the non-clinical modules of the Common Technical Document (CTD) Implementation of biocompatibility assessments according to the ISO 10993 standard series and other relevant regulatory requirements Conducting toxicological risk assessments according to ISO 10993-17, ICH M7 and ICH Q3 Implementation of safety assessments for cosmetic products Preparation of Environmental Risk Assessments for Medicines Review and revision of the non-clinical content of product information documents (e.g. specialist information, package leaflet, instructions for use) Representation of the preclinical strategy in scientific advisory procedures for medicinal products authorities and in structured dialogue with notified bodies Compilation of scientific documentation, expert opinions and regulatory submissions Implementation of systematic literature research and analysis and evaluation of relevant data Planning and control of preclinical studies in accordance with ICH-GLP and other applicable standards for medicines and medical devices Critical evaluation and interpretation of preclinical study results

University degree in Life Sciences or a comparable subject Ideally additional qualification as toxicologe (m/w/d) Knowledge gained in at least one regulatory framework, combined with the willingness to expand knowledge to further regulatory areas At least three years of relevant professional experience in the pharmaceutical or medical technology industry or in a CRO Proven Scientific Writing Experience Excellent written and oral language skills in English and German

Customer and solution orientation – for us the ''DNA' of a professional service provider Experience, expertise and globally active networking in more than 90 countries through the regulanet® network founded by us* Long-standing and innovative customers who are honestly recommending A team-crossing personal and active, living together An attractive, bright and modern working environment What you get International diversity – in the team and in the projects Long-term perspective, professional and personal development, interesting tasks and individually tailored training opportunities Flexibility, freedom and self-responsibility – through flat hierarchies, short decision-making and family-friendly working time models, for everyone ... Work in one of the most beautiful regions of the country, also called the TuscanyGermany, at the edge of the Black Forest in the tri-country corner Germany / France / Switzerland Remote work solutions possible after consultation Attractive salary, occupational retirement, asset-effective services, JobRad, Hansefit, Corporate Benefits, Shuttle transfer Freiburg-Badenweiler and much more