Menu

Leïla-Pauline COLLET

LONDRES

En résumé

Highly motivated Senior Regulatory Associate, seeking challenging opportunities in the Pharmaceutical Industry and especially in the Drug Registration space.

Entreprises

  • ADEDIEM Association - Université de Paris-Sud 11 - Secretary of the ADEDIEM

    2012 - 2013 The ADEDIEM is an association of regulatory affairs alumni who studied Masters in International Drug Development and Registration
    Paris-Sud-11 University
    · Organised the ADEDIEM conference day on:
    . The New Phamacovigilance legislation
    . Innovation in the pharmaceutical industry

  • GlaxoSmithKline - United-Kingdom - Senior Regulatory Associate

    2012 - 2015 New Chemical Entity (waves 1, 2, 3)
    - Lead International regulatory submission strategy
    - Supported EU initial submission and responses to questions
    - Coordinated dossiers and market specific requirements preparation and dispatch
    - Ordered registration samples

    Compounds in development
    - CTAs and Amendments submissions, 3rd parties involvement
    - PIPs, DSUR
    - Paediatric compliance team member

    Lifecycle management of marketed products (CP mainly and MR/DCP)
    - Scientific Advice
    - Annual Reassessment, Annual renewal, Administrative rMRP submission strategy
    - Article 46 paediatric submissions, PSURs, Article 31 referral,
    - Variations, Responses to questions, licence cancellations, labelling reviews.
    - Mentoring and buddying

  • Cap Indus Association - Université de Rennes 1 - Communication Manager

    2011 - 2011 Cap Indus Association (CIA)
    Created in 2007, the CIA brings together students who intend to work in the pharmaceutical industry.
    · Organisation of the Forum des Industries de la Santé du Grand-Ouest.
    · Attended a pharmaceutical congress on quality management in Biarritz, France.

  • Biolotus Biotechnology - Lisbon - Regulatory Affairs Trainee

    2011 - 2011 Topic: "International registration of biotechnological products and medical devices"
    · Updating registration dossiers into European CTD format
    · Leaflets and SPC creation for initial submission in French speaking African countries
    · Artwork review

  • D&A PHARMA - Paris - Regulatory Affairs Trainee

    2010 - 2010 Topic: "Compassionate use and clinical trials, regulatory involvement"
    · Comparison of national "compassionate use" programs
    · Selection of countries where the company would start the program.
    · Contribution to pre-IND meeting dossier preparation
    · Introduction of the VHP to the Regulatory Affairs department

Formations

  • Université Paris 11 Paris Sud (Chatenay Malabry)

    Chatenay Malabry 2011 - 2012 Masters in International Drug Development and Registration

  • Université Rennes 1 (Rennes)

    Rennes 2006 - 2012 Completion of 6-year course in Pharmacy

Réseau

Annuaire des membres :