Bertine Vorstenbosch – de Wijs

Freelance RA CMC Specialist

✔

Vorstenbosch Regulatory Support

Dreefhoef 6, 5291 NN, Gemonde, The Netherlands +31 6 232 07 407 E-mail: [email protected]

Career Objective

Regulatory and/or Quality Affairs

assignments in which I can use/share my professional knowledge and experience, demonstrate my skills and contribute to the company.

Summary of Qualifications

 English communication according to Common European Framework of Reference, CEFR B1.2 Threshold  QA Officer for study, process and facility based GLP audits  Business Development support

Achievements

  

Publication Bachelor of Science

degree in Chemistry

Thesis

Investigate the synthesis of Narrow Range ethoxylation catalysts. Testing of homogeneous and heterogeneous ethoxylation catalysts

Behavioral Competencies

      Working independently (under limited supervision) Good written and verbal communication skills Problem solver Action oriented (vigorous, persistent and consistent approach) Ability to critically analyze (in depth studies) Accurate (eye for detail)      Team player Versatile learner Flexible Well organized Work well under time pressure 1998 1992 1992

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Professional Experience

             Identifies, obtains, generates, reviews and compiles regulatory documents concerning Chemistry Manufacturing Control (CMC) related issues that are needed for international Health Authorities (HA) submissions including EDMF (Applicants & Restricted Parts), IND, NDA, ANDA, annual reports, IMPD, MAA, CMC variations, Quality Overall Summaries, etc. Reviews regulatory documents with respect to regulatory compliance by evaluating data for accuracy, completeness, suitability and acceptability (compliance check / gap analysis). Provides regulatory impact assessment on change control requests proposed by departments involved (in manufacturing, packaging, distribution and analytical testing of the drug substance as well as the drug product). Makes proposals to the organization with regard to the submission strategy required for proposed CMC changes / variations. Makes recommendations to improve compliance and to anticipate on potential questions from Health Authorities. Answers questions from local RA Managers and Health Authorities (worldwide) and coordinates the Agency Response process. Consults with the departments involved. Generates, coordinates, reviews and finalizes procedures, protocols, studies (which are performed by the chemical/pharmaceutical disciplines) and reports to meet HA commitments, to maintain global registrations and to ensure compliance. Draws independently conclusions regarding the results obtained. Assesses DMFs of third party API suppliers. Examines whether the data of the API for drawing up the DMF comply with applicable national and international registration requirements and applicable GMP guidelines. Determines independently when and how the DMF should be adjusted and discusses the changes to the API section with third party API suppliers and other departments. Consults with third party API suppliers involved about the planning and progress regarding available registration documentation and/or Health Authorities questions. Provides the filing of DMF’s for customers. Participates in product development team meetings, including early and late stage development, to ensure inclusion of CMC requirements across various stages of the drug development/approval process. Provides guidance and guidelines to teams on issues impacting CMC dossiers including appropriate content in CTD format. Gains general understanding of technical, clinical and commercial manufacturing developments that may impact regulatory submissions and approvals. Develops working knowledge of regulatory standards, practices, corporate policies and SOPs. Stays up-to-date with the expertise in the relevant areas. Sees to planning, coordination and implementation of all the tasks related to her project. Has contacts with local companies and other sister companies. Is conversant with relevant, world-wide registration requirements. Is conversant with literature relevant to the projects and products assigned to her. Assists with training of new regulatory professionals (Training Coordinator). Acted as TIER 1 Lead: resolving system and procedure specific problems/issues on the work floor in order to optimize daily work for MSD In-Line Support group (6 - 8 team members).

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Software Applications

Lorenz DocuBridge, Nanokinetik READY! for Regulatory Affairs, Sparta Systems’ TrackWise, EMC Documentum, LIQUENT InSight for Registrations (ORION), ArisGlobal Register TM (GReAt), Qumas DocCompliance 1.3.2, etc.

Employment History

        

Vorstenbosch Regulatory Support (Gemonde, The Netherlands)

Freelance RA CMC Specialist

Disphar International B.V. (Baarn, The Netherlands)

Regulatory Affairs Project Manager

MSD (Oss, The Netherlands)

Senior Specialist, Regulatory Affairs / Biologics CMC (GRA-CMC) Senior Specialist, Regulatory Affairs / In-Line Support & CMC Support EU (GRA-CMC)

Kinesis Pharma BV (Breda, The Netherlands)

Consultant CMC Regulatory Affairs DMF Consultant QA Officer

Synthon BV (Nijmegen, The Netherlands)

DMF Manager DMF Officer Chemical R&D Scientist

NV Organon (Oss, The Netherlands)

R&D Scientist (Organic Chemistry)

Organic Chemistry Department of the University of Nijmegen (Nijmegen, The Netherlands)

Research Analyst (Laboratory for Large Scale Synthesis) 

Diosynth BV (Oss, The Netherlands)

Regulatory Affairs Assistant

Education

    HLO-Organic Chemistry, Arnhem Institute of Laboratory Science (University of Applied Sciences in Arnhem, The Netherlands) Bachelor of Science degree in Organic Chemistry HLO-Preliminary examination “Propaedeuse”, Hogeschool Eindhoven (University of Applied Sciences in Eindhoven, The Netherlands) MLO-Chemistry, Hogeschool Eindhoven (University of Applied Sciences in Eindhoven, The Netherlands) MAVO (Vlijmen, The Netherlands) 2015 – current 2015 – current 2014 – 2015 2012 – 2014 2006 – 2012 2004 – 2006 2004 – 2005 2002 – 2004 2000 – 2002 1999 – 2000 1993 – 1998 1993 1992 1992 1989 1987 1984

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Internship

 CHEM-Y GmbH (Emmerich, Germany)        

Relevant Courses

       “Master Class Effective Meetings” (Language Institute Regina Coeli).

“

Het voor toediening gereedmaken van klinisch studiemateriaal onder GMP

”

(GMP-Themadag DARQA).

“Active Pharmaceutical Ingredients GMP and Regulatory Affairs Conference” (APIC/CEFIC 12 th European API Conference, Venice, 18-20 November 2009).

“Chemistry and Pharmacy Registration Requirements” (David Begg Associates). “Impurities” (European Compliance Academy in co-operation with Concept Heidelberg). “Good Laboratory Practice” (Center for Professional Advancement). “CTD, CEP and DMF Quality of Drug Substance” (European Compliance Academy in co-operation with Concept Heidelberg). “Salt Formation, Selection and Optimisation” (Synthon BV). “Pharmaceutical Applications in the E.U.” (Management Forum). “Qumas DocCompliance 1.3.2” (Synthon BV). “Pharmaceutical Certification and Active Ingredient Requirements in the E.U.” (Management Forum). “GMP Aspects of API manufacture” (David Begg Associates). “Pre Approval Inspection” (Synthon BV). “Cursus Engels Schriftelijke Taalvaardigheid 2” (NIOW advies & opleiding). “Cursus Engels Schriftelijke Taalvaardigheid 1” (NIOW advies & opleiding).

Publication

1992 2011 2009 2009 2007 2005 2005 2004 2003 2003 2002 2001 2001 2000 1996 1995 Basten JE, Dreef-Tromp CM, de Wijs B, van Boeckel CA, Bioorg Med Chem Lett. 1998 May 19;8(10):1201-6. In vitro evaluation of synthetic heparin-like conjugates comprising different thrombin binding domains.