A 5th year pharmacist student in France, I have gained knowledge of drug life cycle and pharmaceutical environment. I am looking for an internship in regulatory affairs to learn more about the drug regulations and to put in practice what I have learned in University about registration procedure. After my studies I want to work in international registration.My skills:◆ Drug development and registration procedure: industrial course in France with a strong training on regulations and market access◆ Approach of the whole pharmaceutical environment with internships in dispensaries and hospitals◆ Team work learned through numerous project in university and associative life◆ Project management: organizing summer camps and overseeing summer camp planningI want to make a difference in people's life by improving their health. I am driven and enjoy the challenge of working in the cutting-edge that Pharmacy is.
-
Chargée D'Affaires Réglementaires Nouveaux EnregistrementsLaboratoires Théa Sep 2024 - PresentClermont-Ferrand, Auvergne-Rhône-Alpes, France
-
Alternante Affaires Règlementaires Nouveaux EnregistrementsLaboratoires Théa Aug 2023 - Aug 2024Clermont-Ferrand, Auvergne-Rhône-Alpes, France
-
Regulatory Affairs InternOm Pharma May 2020 - Dec 2020Meyrin, Geneva, SwitzerlandPorfolio EU + CH : 2 microbial immunotherapies, 4 products in vascular pathologies• Preparation and submission of CCDS variations with PIL and SmPC following an EU referral under article 31 of regulation 2001/83/EC.• Preparation and submission of several grouped CEP variations (API and excipients) of type IA and IB for the 6 products in the portfolio.• Database monitoring: Trackwise.• Regulatory intelligence: transfer of MA in Europe (budget, timeline, issues) -
Regulatory Affairs InternBiogen May 2019 - Aug 2019Courbevoie, FrancePortfolio: Multiple sclerosis (5 products), spinal muscular atrophy (1 product), 3 biosimilars. • Implementation of MA variations in the official documents of the subsidiary (legal mentions).• Verification of labeling.• Verification of non-promotional material.• Optimisation of the tools for monitoring the implementation of MA variations and promotional material on the positive list.• Preparation of the audit of the promotional information charter. -
Pharmacist InternHôpital D’Instruction Des Armées Robert-Picqué Jan 2019 - Apr 2019Villenave D'Ornon, France• Analysis of drug prescriptions and dispensing.• Carrying out an audit of narcotics.• Exploiting the feedback from the certification by the 'Haute Autorité de Santé' with the Quality Unit.• Carrying out an inventory of implantable medical devices.
Anne-Constance Berger Education Details
-
Master 2 Erieps - Environnement Règlementaire International Des Entreprises Et Produits De Santé -
Medicine -
Pharmaceutical Sciences
Frequently Asked Questions about Anne-Constance Berger
What company does Anne-Constance Berger work for?
Anne-Constance Berger works for Laboratoires Théa
What is Anne-Constance Berger's role at the current company?
Anne-Constance Berger's current role is Regulatory Affairs Trainee.
What schools did Anne-Constance Berger attend?
Anne-Constance Berger attended Université De Montpellier, Sorbonne University, Bordeaux University.
Who are Anne-Constance Berger's colleagues?
Anne-Constance Berger's colleagues are Wassim Menidjel, Cédric Dauphin, Emmanuelle Renaudineau, Mohammed Amine Daghi, Coralie Tarrieu, Nicoleta Babuscov, Maria Molina Duran.
Free Chrome Extension
Find emails, phones & company data instantly
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial