Fleur Douy Email & Phone Number

Melbourne, Australia

Melbourne, Australia

• Management of a given product list portfolio to ensure relevant prescription medicine submissions such as Category 1 & 3, variation submissions, sponsor transfers and regulatory queries are submitted for new product registrations and existing products maintenance. • Coordination of the launch of new generic products including gaining TGA approval and PBS listing • Submission of OTC applications for new products and maintenance of product portfolio.• Review of European CTD dossiers… Show more • Management of a given product list portfolio to ensure relevant prescription medicine submissions such as Category 1 & 3, variation submissions, sponsor transfers and regulatory queries are submitted for new product registrations and existing products maintenance. • Coordination of the launch of new generic products including gaining TGA approval and PBS listing • Submission of OTC applications for new products and maintenance of product portfolio.• Review of European CTD dossiers for Australian submissions for generic products (Category 1 application & variation dossiers) to ensure received documentation complies with international standards such as ICH guidelines, BP, Ph.Eur. or USP monograph and TGA standards such as Therapeutic Goods Order.• Coordination of Actavis re-branding in collaboration with marketing and logistic department to plan re-branding (new name, new packaging) at the most appropriate time to minimize costs.• Preparation and submission of applications to maintain products I am responsible for in line with TGA and international standards.• Coordination and development of PI, CMI, packaging artwork and CPD to ensure the most updated version is provided to TGA, external organizations and websites or relevant partner.• Performed in quality functions such as checking CoAs and approval for distribution for received stocks.• Managed renewals and coordination of GMP site clearances for manufacturing sites of products. Show less

Melbourne, Australia

Paris Area, France

• Submission of new generic and OTC products dossiers.• Writing and submission of variation dossier (type IA, IB and type II).• Re-formatting of old Marketing Authorization dossier from NTA format to CTD format for new submission to obtain clone products.• In charge of the regulatory aspect of the launch of the first OTC line for the company. This included obtaining approval for new OTC medicines, participation to branding meeting with marketing and strategy and development teams… Show more • Submission of new generic and OTC products dossiers.• Writing and submission of variation dossier (type IA, IB and type II).• Re-formatting of old Marketing Authorization dossier from NTA format to CTD format for new submission to obtain clone products.• In charge of the regulatory aspect of the launch of the first OTC line for the company. This included obtaining approval for new OTC medicines, participation to branding meeting with marketing and strategy and development teams and artwork coordination.• Artwork development in line with local requirements and marketing requirements. Show less

Master'S Degree, Droit De La Sante

Bachelor Of Pharmacy (B.Pharm.)