Cologne, North Rhine-Westphalia, Germany
Experienced Project Manager and Certified Ecotoxicologist (SETAC GLB, GDCh) with a demonstrated >10 year history of working for an international service provider and the chemical industry. Skilled in ecotoxicology, environmental fate, regulatory affairs (REACh, BPR) and CLP.
* Management of REACH activities (e.g. registrations, strategic decisions within product development, planning of experimental studies) * Management of data sharing for EU-REACH and other international chemical legislationsq * Joint Submission Management * Monitoring of SVHC substances and other substances of concern * Sharing my broad ecotoxicological knowledge for designing new studies and reliability assessments of existing studies * IUCLID 6
Preparation of dossiers for Regulation (EC) No 1907/2006 (REACh), Regulation (EU) No 528/2012 (BPR) and Environmental Risk Assessment (ERA) for medicinal products for human use according to Directive 2001/83/EC * Data gap analysis * Study monitoring of ecotoxicological studies * Study evaluation * Application of (Q)SAR models * Classification and Labelling according to CLP * Waiving strategy * Grouping and read-across according to RAAF * Chemical Safety Report (CSR) * PBT assessment * Environmental exposure assessment (ECETOC TRA, easyTRA, Chesar) * Preparation of the Annex for Extended Safety Data Sheets (eSDS) * IUCLID 6