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Aurore LACROIX

MASSY

En résumé

- 8 years of experience in Regulatory Affairs (North America and Europe)
- Combine science and regulatory affairs background
- Liaise with external regulatory agencies (EMA, EU national agency, Health Canada and FDA)
- Maintain awareness of current and new legislation/guidance and ensure that MA folders are in compliance with the statutory requirements.
- Lend support to cross-functional teams to ensure CMC guidelines are followed in compliance with industry standards
- Manage regulatory assessments on topics including change controls, deviations and GMP
- Ensure systems and procedures (SOP) are up to date
- Manage several projects simultaneously
- Products: ATMP, Immunothérapy, sterile and modified release drug products,
- Excellent verbal and written communication and presentation skills


Mes compétences :
Affaires réglementaires
AMM
Brevet
Droit
EMEA
FDA
Intellectual property
International
Santé

Entreprises

  • Genosafe - Regulatory Affairs Officer

    2013 - maintenant Advanced Therapy Medicinal Products (ATMP) -
    • Prepare, submit and follow-up Orphan Drug Designation (ODD) and clinical trials
    • Classification of ATMP
    • Prepare and submit GMO’s application in accordance with national regulation (FR)
    • Prepare team training on ATMP regulations
    • Prepare scientific advice procedure
    • Ex-vivo Gene therapy medicinal product

  • Actavis France - Regulatory Affairs Officer

    2012 - 2013 Chemical drug product (prescription, OTC and hospital)
    • Managed a drugs portfolio of around 200 MAs/20 active substances
    • Prepare, submit and follow-up variations (safety and CMC)
    • Guidance to manufacturing and biological assay on regulatory requirements
    • Manage the change controls with the different departments (manufacturing, quality…) and submit variations for implementing the changes
    • Request and manage national requirements after a centralised procedure
    • Prepare documentation required to support QP release of compliant product
    • Review of promotional materials and labelling

  • Viventia Biotechnologies Inc - Associate Manager Intellectual Properties and Global Regulatory Affairs

    2011 - 2012 Intellectual property and Global Regulatory Affairs

    • Managed the patent portfolios recorded and allowed throughout the world (22 patents submitted at the minimum in US, CA, EPO, JP,CN)
    • Examined “Office Action” and/or “Restriction Requirement” and argued to respond to the examiner
    • Communicated with patent and trade-mark agents
    • Ability to interpret WIPO/USPTO/CIPO/EPO patent laws and regulations
    • Discussed and analysed the patentability of innovations proposed by R&D (by prior art search using database)
    • Examined the various references in order to inform on barriers, opportunities and research directions that can explore R&D.
    • Analysed the patents filed by competitor (competitive intelligence)
    • Analysed the economic market according to our business and our budget to identify the countries where it is important to file the patents.



    Scientific

    • Cancerology (Head and neck, bladder, breast)
    • Antibody/antigen
    • Protein recombinant
    • Immunotoxin
    • Immunology
    • Software: BLAST, FASTA, Clustal, PRSS-PRFX Identity sequence, PUBMED

  • ACTAVIS France - Regulatory Affairs Officer

    2009 - 2009 Chemical drug product (prescription, OTC and hospital)
    • Submit and maintain Marketing Authorization (MA) for a specified portfolio
    • Coordinate the Chemistry Manufacturing and Controls (CMC) parts of applications
    • Update and develop national texts (e.g. SmPC, PIL and packaging artworks)
    • Implement different strategies in order to meet evolving regulatory (to obtain MA or variation in a minimum of time, to avoid/limit agencies’ questions)

  • Focal Point Research, Toronto - Senior Regulatory and Scientific Affairs Associate

    2009 - 2011 Senior Associate Scientific and Regulatory Affairs

    Drug& Natural Health Products/Cosmetics
    • Representation of clients at Health Canada or FDA meeting
    • Prepare and manage self-inspection
    • Prepare and manage the submission of NDA/DIN/NHP/cosmetics
    • Review Packaging according to the INCI dictionary, Cosing and national claims
    • Prepare and review batch record of drug products

  • MEDIPHA SANTE SN - Chargées affaires réglementaires

    2006 - 2009 Chemical drug product (prescription, OTC and hospital)
    • Audit the Chemistry Manufacturing and Controls part of ASMF and finished product
    • Prepare, submit and follow-up Marketing Authorization Applications (MAA)
    • Identify and initialized the best strategy for MAA and answer to questions
    • Prepare the answer to agencies’ question

Formations

  • Academy For Applied Pharmaceutical Science AAPS (Toronto)

    Toronto 2010 - 2010 Professional regulatory affairs - Canada and USA

    - GMP Certificate
    - Regulatory affairs submission certificate
    - Pre-clinical test submission
    - NHP certificate

  • Université Paris 11 Paris Sud (Chatenay Malabry)

    Chatenay Malabry 2008 - 2009 Master Professional - Management et marketing pharmaceutique

  • Université Lille 2 Droit Et Sante

    Lille 2005 - 2006 Master Professional - Droit de la santé - Affaires règlementaires

  • Université Paris 11 Paris Sud

    Orsay 2004 - 2005 Master Research - Neuroscience

    DEA neuroscience

  • Université Limoges

    Limoges 2002 - 2004 biochimie, biologie moléculaire et cellulaire

  • Lycée Raoul Dautry

    Limoges 1997 - 2000 S.T.L Biochimie Génie biologique

Réseau

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