Francesca Genisio Email & Phone Number | I’m working in Regulatory Affairs area from many years, my activities and responsibilities are: - Construction documentation for the renewal of marketing authorizations with a national procedure; -Setting up the application for authorization of a drug with the national registration procedure; -Preparation of variations to medicinal products in line with Regulation 1234/2008/CE; -Assuring the creation, revision and approval of the artworks of packaging and promotional materials in accordance with the regulation of the local Health Authorities; - Providing support for Q.P. and management of departmental documentation. ; -Revision and submission of product information documents; - Preparation and updating of DMF/dossiers (Modules 1, 2 and 3 in CTD format) for the registration of products in Italy (and Europe with national, decentralised and mutual recognition procedures) ; -Management of the regulatory aspects concerning variations, renewals, line-extensions and revisions; - Translation in meantime of Summary of Products Characteristics (SmPC)/Patient Information Leaflet (PIL)/Label of products; -Revision of Batch Records; - -Keeping and developing relationship with Institutions; -Implementing activities required to secure regulatory clearance/approvals for new and revised product lines; - Fulfilment of legal requirements for each product (first marketing, variations, renewal, suspension …); -Cooperation with manufacturing plants (Italy and abroad) in preparation of the required documentation to apply for variations of the products Marketing Authorisation (declarations, stability data, certificates of analysis, chemical documentation updating) ; -In the import/export procedures ; -Cooperation for reimbursement and price application incl. price negotiation with the authorities activities. Temporary collaboration in QA

Francesca Genisio

I’m working in Regulatory Affairs area from many years, my activities and responsibilities are: - C...
Latium, Latium, Italy

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Francesca Genisio’s Email francesca.genisio@worldwide.com

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Francesca Genisio’s Location Latium, Latium, Italy

Francesca Genisio’s Current Industry Miur

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Work Experience

Miur

Insegnate

2022-09-01 00:00:00 - Present

Worldwide Clinical Trials

CRA II

2020-01-01 00:00:00 - 2020-12-01 00:00:00

Covance

CRA

2018-06-01 00:00:00 - 2020-01-01 00:00:00

Crasecrets Com

Writer

2016-04-01 00:00:00 - 2017-03-01 00:00:00

Ln Age

Clinical Research Associates. CRA Certification as per Italian M.D. 15 Nov 2011.

2016-05-01 00:00:00 - 2017-01-01 00:00:00

Novartis

Regulatory affairs operations

2014-01-01 00:00:00 - 2014-12-01 00:00:00

Abbott

QUALITY ASSURANCE_EPD PLD COMPLIANCE TECHNICIAN

2012-12-01 00:00:00 - 2013-11-01 00:00:00

Ramini

REGULATORY AFFAIRS MANAGER

2011-09-01 00:00:00 - 2012-11-01 00:00:00

Sanofi Pasteur Msd

ASSISTENT REGULATORY AFFAIRS - Q.A. presso Sanofi Pasteur MSD

2011-03-01 00:00:00 - 2011-09-01 00:00:00

Studio Svimm Sviluppo And Marketing

Stagista

2010-08-01 00:00:00 - 2011-02-01 00:00:00

Promopharma

informatore scientifico

2010-06-01 00:00:00 - 2011-02-01 00:00:00

Scuola Aspei

Insegnante Dermocosmesi-Biologia-Chimica

2010-10-01 00:00:00 - 2011-01-01 00:00:00

Farmacia Imbesi

Farmacista

2007-05-01 00:00:00 - 2009-05-01 00:00:00

Farmacia Albertazzi

Farmacista

2006-07-01 00:00:00 - 2007-07-01 00:00:00

Skills

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Languages

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FAQ About Francesca Genisio

Francesca Genisio is located at
Latium, Latium, Italy

Francesca Genisio is a I’m working in Regulatory Affairs area from many years, my activities and responsibilities are: - Construction documentation for the renewal of marketing authorizations with a national procedure; -Setting up the application for authorization of a drug with the national registration procedure; -Preparation of variations to medicinal products in line with Regulation 1234/2008/CE; -Assuring the creation, revision and approval of the artworks of packaging and promotional materials in accordance with the regulation of the local Health Authorities; - Providing support for Q.P. and management of departmental documentation. ; -Revision and submission of product information documents; - Preparation and updating of DMF/dossiers (Modules 1, 2 and 3 in CTD format) for the registration of products in Italy (and Europe with national, decentralised and mutual recognition procedures) ; -Management of the regulatory aspects concerning variations, renewals, line-extensions and revisions; - Translation in meantime of Summary of Products Characteristics (SmPC)/Patient Information Leaflet (PIL)/Label of products; -Revision of Batch Records; - -Keeping and developing relationship with Institutions; -Implementing activities required to secure regulatory clearance/approvals for new and revised product lines; - Fulfilment of legal requirements for each product (first marketing, variations, renewal, suspension …); -Cooperation with manufacturing plants (Italy and abroad) in preparation of the required documentation to apply for variations of the products Marketing Authorisation (declarations, stability data, certificates of analysis, chemical documentation updating) ; -In the import/export procedures ; -Cooperation for reimbursement and price application incl. price negotiation with the authorities activities. Temporary collaboration in QA

Francesca Genisio currently works in the Miur |

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Francesca Genisio has prior
experience in the following industries:
Worldwide Clinical Trials | Covance | Crasecrets Com | Ln Age | Novartis | Abbott | Ramini | Sanofi Pasteur Msd | Studio Svimm Sviluppo And Marketing | Promopharma | Scuola Aspei | Farmacia Imbesi | Farmacia Albertazzi

Francesca Genisio has the following professional experience:
Miur | Worldwide Clinical Trials | Covance | Crasecrets Com | Ln Age | Novartis | Abbott | Ramini | Sanofi Pasteur Msd | Studio Svimm Sviluppo And Marketing | Promopharma | Scuola Aspei | Farmacia Imbesi | Farmacia Albertazzi