Margot Timmermans

Project 1: Sep 2021 - Dec 2022; Global CMC RA Consultant Covid-19 Vaccine J&J: Primary scope: defining and preparing global submissions for variations regarding the Covid-19 vaccine. Main focus on filing to EMA (MAA), in addition FDA (EUA), WHO (EUL), India, Canada, and rest-of-world. Defining regulatory submission strategies and directly involved in negotiating submission strategies with health authorities (EMA and India). Lead and responsible for handling variations including addition of new manufacturers. eCTD M1, M2.3, M3 (MAA, EUA) documentation preparation, authoring, review, approval. Handling post-marketing commitments and response to questions from Health Authorities. Liaising with health authorities, internal stakeholders, external parties (e.g. contract manufacturers) on submission and implementation strategies. Implementing process and project improvements within the CMC RA activity scope.

Authoring and redacting of Quality documentation (CTD Module 3; Chemistry, Manufacturing and Control) for regulatory submissions of clinical trial and/or marketing applications (IMPD, IND, IB, MAA, NDA). Early and Late Stage of Development (From First-in-Human to Phase 3 Clinical Trials) to Commercialization Addressing CMC inquiries from Competent Health Authorities Define strategy for CMC dossier approach for upcoming submissions Dossier development activities including creation of IMPD/IND templates appropriate for different stages of development Additional trainings: Effective Communications Skills (30 h) Sep 2020 BRAS advanced course CTD Module 3 Quality Section (16 h) Nov 2019

Reporting to: Managing Director Praxair BeNeLux (Mar 2017 - Dec 2018) Previously to: Director QSEH Praxair Germany-BeNe (Sep 2014 - Feb 2017) Team: 1 direct report (Quality Engineer) Scope:

- Products: gases (cryogenic (liquid), compressed, liquefied, dissolved, solid (dry ice)) for various applications/industries (medical, food&beverage, electronics, metalfab, chemicals, environmental, ...)

- BNL region: 9 sites (air separation units (incl pipeline), filling/manufacturing sites, distribution centra) Qualified Person:

- Products: Medicinal Gases (API and finished drug product manufacturing, medical devices and magistral preparations)

- Responsible pharmacist for Marketing Authorization Holder Praxair NV and Praxair BV

- Overall lead and accountable for pharmaceutical quality system/activities responsible to ensure compliance with GMP, GDP, ISO 13485, applicable legislation and standards

- batch certification and batch release/disposition

- control and end-responsibility for distribution Quality Manager:

- Responsible for the integrated quality management system: GMP/GDP, ISO 9001 (Quality management), ISO 13485 (medical devices), HACCP (food), ISO/IEC17025 (accreditation), ISO/TS16949 (automotive)

- Accountable for quality matters and quality performance of the integrated management system

- Management representative for ISO norms

- Operational quality support (training, change management, document management, complaint/deviation handling, action management, ...)

- Set quality policy and objectives; follow up, reporting and continuously improvement of the quality performance

- Contact point for authorities and internal/external parties on quality matters

- Audit lead for internal audits (plan, execute, follow up) and external audits (authorities, NoBo, Customers) Additional training:

- German (120h)

- Finance for managers (120h)

- Lean (16h)

- Quality systems: ISO9001:2015 transitioning; ISO22000:2005 (food); ISO13485:2003 (medical devices) (16h each)