NABILA ACHARIF
INGENIEUR PHARMACEUTIQUE
DRAGUIGNAN
Vue d'ensemble
7
7
years of professional experience
2
2
years of post-secondary education
Expérience
TMF Manager
SANOFI
Gentilly, France
10.2022 - Actuel
- Management of the eTMF of several clinical studies
- Ensure that all the expected documents are well filed in the eTMF on time, in accordance with regulations
- Set up of quality check to be compliant
- Set up of meetings with all the contributors of the eTMF: Kick Off Meeting, status, Closure, Pre and Lock meeting
Regulatory Project Planning Manager
SANOFI
Chilly Mazarin, France
05.2019 - 09.2022
- Management of regulatory activities for the portfolio project of Sanofi R&D Pharma (US/EU/CHINA/JAPAN)
- Planning management (Cost, Resources and timelines)
- Responsible of Process Financial Valuation of regulatory affairs department
- Template Maintenance (creation/updates of China Template)
- Support for RDPM Project: V6 testing phase and building templates
- Export and analyse of data for Management and Financial Services (Submissions of CTDs, costs for Regeneron Projects)
Project Planning Manager
SERVIER
Suresnes, France
10.2017 - 04.2019
- Planning management of R&D Projects
- Multi management projects on various therapeutic areas
- Creation of scenarios based on various hypotheses of products development
- Creation of project schedules (Research, Development, Post-Marketing)
- Implementation of planning reports: Timelines, costs, and resources
- Implementation of a planning guide gathering the processes and the best practice of project management of the group Servier
Regulatory Planning Manager
GALDERMA
Sophie Antipolis, France
04.2016 - 09.2017
- Regulatory Planning Management of Galderma Portfolio (Functional Planning)
- Implementation of a tracking tool at the Marketing Authorization stage: the CTD tracker
- Analysis and monitoring of activities of Regulatory Affairs Department (costs, deadlines and resources)
- Alert and support the project teams
- Development of load plans, simulations, impact analysis, critical path
- Update and creation of templates projects
Formation
Master - ingénierie de la santé - management de projets en environnement santé
Université de Montpellier - IUP Santé
01.2015 - 01.2017
Compétences
- Planisware V5
- Planisware V6
- Planisware V7
- Viva Vault Clinical (eTMF)
- TrialView
- Viva Vault RIM
- MS project
Informations complémentaires
- Activités associatives
- Voyages (Road trip en asie)
- Pratique du basketball, natation et fitness
Langues
Francais
Langue maternelle
Anglais
Courant
Espagnol
Intermédiaire
Chronologie
TMF Manager
SANOFI
10.2022 - Actuel
Regulatory Project Planning Manager
SANOFI
05.2019 - 09.2022
Project Planning Manager
SERVIER
10.2017 - 04.2019
Regulatory Planning Manager
GALDERMA
04.2016 - 09.2017
Master - ingénierie de la santé - management de projets en environnement santé
Université de Montpellier - IUP Santé
01.2015 - 01.2017
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