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Amira AkchicheAA

Amira Akchiche

Affaires Réglementaires Freelance

€850/day
Montpellier, FR
15+ years

Average response time: 1 hour

About Amira

Manager of Regulatory Affairs, in Corporate structures of pharmaceutical companies, primarily focused on EU/US/International Drug Development and Registration activities, having also encompassed all aspects of Life Cycle Management for Medicinal Products and Medical Devices.

Has worked on drug products at international level, with quick identification of scientific, regulatory, and business issues.

Long standing communication and Functional practice acquired on site with Manufacturing & Controls, Non-clinical, Clinical, Quality Assurance, International Departments, affiliates and distributors beyond necessary knowledge of relevant Regulations for such functions.

Planning and organizational skills, strategy and execution-driven at same time. Ease with cross-functional matrix working environment.

Customer needs and solutions orientated, team-spirit driven. Leadership skills with abilities to mix and develop talents in a group. Ease with top management level and multicultural communication.
  • French

    Native or bilingual

  • English

    Fluent

Remote only
Primarily works remotely

Experience

  • Stallergenes Greer
    Global Senior Regulatory Affairs Manager
    PHARMACEUTICALS INDUSTRY
    January 2007 - July 2016 (9 years and 7 months)
    Antony, France
  • Zimmer Biomet
    Senior RA Expert
    PHARMACEUTICALS INDUSTRY
    June 2017 - March 2019 (1 year and 8 months)
    Montpellier, France
  • Sanofi
    Global RA-CMC Coordinator
    PHARMACEUTICALS INDUSTRY
    March 2018 - March 2019 (1 year)
    Montpellier, France

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Education

  • M2 Affaires Régelementaires et Droit de la Santé
    Université Paris Sud
    2013
  • Ingénieur Chimiste option Génie Pharmaceutique
    Ecole polytechnique de Montréal
    2005

Skill set (10)

Categories

  • Other