Experience

Annion

• Spain
• Business Consulting and Services
• 1 - 100 Employee

• Managing Partner & Regulatory Toxicologist

  • Jan 2021 - Present



Self employed

• Toxicology Consultant

  • 2019 - Present

  Occupational Exposure Bands/Categories for APIs, Occupational Exposure Limits (OEL), Permitted Daily Exposures (PDE), Acceptable Daily Intakes (ADI), Limits Setting for Impurities (Q3A, Q3B, Q3C, Q3D, M7, limits based on toxicological data), Risk Assessment on Genotoxic/Mutagenic Impurities including QSARs and expert review, Toxicological Evaluation of Extractables & Leachables, Risk Assessment Reports on Impurities/Contaminants, Risk assessment on Industrial Chemicals, Toxicological reports and strategic response to Regulatory Authorities. Show less



MEDICHEM, SA

• Head of Toxicology & Product Registration

  • 2011 - 2018

  •Occupational Exposure Limits (OELs) for APIs. •Permitted Daily Exposure (PDEs/ADEs) for APIs. •Genotoxic Impurities (ICH M7 guideline). •Impurity limits according to toxicological profile and ICH guidelines (Q3A, Q3B, Q3C, Q3D). •Extractables & Leachables toxicological evaluation. •Toxicological profile and categorization of APIs, chemical intermediates/starting materials and impurities. •Control Banding System Implementation and Maintenance. •Safety Data Sheets (SDS) performance and management. •Toxicological reasonings and risk assessments to regulatory authorities (EMA, FDA, National Agencies, ECHA). •Product Stewardship/Registration: - REACH Implementation (Regulation 1907/2006/EC) Pre-registration, Registration Dossiers, SIEFs management. - CLP Implementation (Regulation 1272/2008/EC) Review of substance physico-chemical, toxicological and ecotoxicological information and classification according to CLP criteria. - Biocidal Products (BPD, BPR) Active Substance Registration, Biocidal Products support - SVHC, PBT/vPvB and CMRs identification Show less



Medichem, S.A.

• Spain
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Process R&D Toxicology, Health & Environment Specialist

  • 2006 - 2010

  •Toxicological profile of new Active Pharmaceutical Ingredients (APIs), chemical intermediates, starting materials and impurities. •Control Banding System Implementation and Maintenance. •Setting Occupational Exposure Limits (OELs). •Material Safety Data Sheets (MSDS) performance and management. •Dealing with Genotoxic Impurities (EMEA guideline and FDA draft guidance). •Toxicological justifications and risk assessments requested by the regulatory authorities (EMEA, FDA, National agencies). •Product Stewardship: REACH Implementation (Regulation 1907/2006/EC) CLP Implementation (Regulation 1272/2008/EC) Directive 67/548/EC Biocides Products Directive SVHC, PBT/vPvB and CMRs identification Directive 2003/101/EC Directive 2455/2001/EC (water policy) VOC Solvents Directive Show less



Medichem, S.A.

• Spain
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• R&D Documentalist

  • 2004 - 2005

  •Market details and patent situation analysis for new product candidates. •Scifinder searches and administration. •New patent applications. •R&D Documentation. •Material Safety Data Sheets performance and management. •Market details and patent situation analysis for new product candidates. •Scifinder searches and administration. •New patent applications. •R&D Documentation. •Material Safety Data Sheets performance and management.



INECSA

• Laboratory Technician

  • Apr 2002 - Apr 2004

  - Research and Development of new formulations, varnishes. - Quality Control tasks. - Cooperation with the International Sales Department. - Research and Development of new formulations, varnishes. - Quality Control tasks. - Cooperation with the International Sales Department.