Joanne WALTSBURGER
À propos du candidat
PharmD – Regulatory Affairs
I am a recent PharmD graduate with a master’s degree in regulatory affairs, complemented by a one-year apprenticeship in publishing.
I am highly motivated to continue growing in my field and eager to take on new challenges.
Localisation
Formations
Pharmacy studies, PharmD Faculty of pharmacy, Paris-Saclay University – Gif-sur-Yvette, France From to • Six years of pharmacy studies, specialized in pharmaceutical industry. • Writing my PharmD thesis on the regulation of Advanced Therapy Medicinal Products (ATMPs).
Master’s degree in regulatory affairs Faculty of pharmacy, Lille University – Lille, France From to • Master AREIPS (European and International Regulatory Affairs of Health Products). • Work-study master with an apprenticeship.
Expériences professionnelles
Electronic dossiers publishing and filing expertise - Apprenticeship SERVIER’S INTERNATIONAL RESEARCH INSTITUTE, Worldwide Regulatory Affairs – Gif-sur- Yvette, France From to • Publishing and submitting CMC variation on CESP portal, publishing safety variation for Switzerland, publishing core dossier for extension of indications. • Formatting documents in eCTD format and assignation of these documents in eCTD dossiers for submission to health authorities in various regions: European Union, Switzerland, Australia… • Organizing trainings on multiple tools for affiliates to help them with their regulatory reviews of various submissions, keeping those tools up to date and conducting frequents quality controls. • Regulatory monitoring of the updates on EMA’s new systems like PLM portal, PMS, and IRIS; and supporting the implementation of eAF and following closely EMA’s pilot on ePIs.
European registration - Internship NOVARTIS FRANCE S.A.S, Regulatory Affairs – Rueil-Malmaison, France From to • Translating variations of marketing authorizations for submission to French authorities and working with medical writing and patient safety departments for review. • Assessing impact of variations in clinical documents for an early-access product. • Ensuring an accurate translation and impression of product’s labelling with visual and text verification tool reviews. • Conducting competitive intelligence in two disease area.
“APIEP” association – Association for the promotion of pharmacy students to industry - President Faculty of Pharmacy, Paris-Saclay University – Gif-sur-Yvette, France From to • Organizing the 36th Forum of Pharmaceutical Industry hosting 40 participants, gathering pharmaceutical companies, business and engineering schools, consulting companies and CROs. • Contacting and keeping in touch with representatives, multiple suppliers, municipality, faculty management and other associations. • Managing a 30 members team and leading weekly meetings. • Operating the administrative and financial management of the association, making decisions while considering multiple time and budget constraints.
eCTD Manager: Publishing tool for regulatory dossiers in various formats (eCTD, ACTD, NeeS, ePaper). Liquent Insight for Viewing: eCTD viewer, administrator’s role.
