Loubna Said Email & Phone Number | Professional experience in the following regulatory activities : In-depth regulatory expertise in originators (princeps), generics, OTC and biosimilar products In-depth knowledge of regulation and guidance in Europe for registration Registration – Outside Europe - Apply regulatory strategy defined by the Group - Registrations, variations and Marketing Authorizations renewal applications for Latin America / Middle East countries and Africa (Maghreb, French speaking Africa countries) Marketing Authorization maintenance – European and national procedures - Marketing Authorizations renewal applications - Clinical variations (safety variations, new indications) - Quality variations - Benefit/ Risk reassessment, referrals, Risk Management plans and minimization plans Commercialization / Market acess - Review and validation of artworks - Review and update legal mentions for marketed promoted products - Regulatory review of promotional materials (global promotional campaign, formation documents) - Constitution of pricing and reimbursement dossiers Others regulatory activities - Responses to medical information requests (infomed) - Manage responses to quality complaints - Ensure the maintenance of regulatory database - Contribute to the establishment, review and maintenance of Standard Operational Procedures for regulatory affairs tasks. Project Management - Manage and coordination of the responses to French Autorities requests in the framework of Benefit/risk reassessment procedures, Risk minimization plans implementation (DHPC…) and Temporary Recommendations for use (RTU) - Activities related to promotional information charter (charte visite médicale) : preparation and coordination of certification audits, participation to audits (intern and subcontractors), ensure the formation of sales forces to the charter or others regulatory items, preparation and coordination of Direction review ... - Implementation of the French regulation regarding pregnancy pictograms

Loubna Said

Professional experience in the following regulatory activities : In-depth regulatory expertise in o...
Greater Paris Metropolitan Region, Greater Paris Metropolitan Region, France

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Loubna Said’s Email loubna.said@tevapharm.com

Loubna Said’s Phone Numbers +1 610-727-****

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Loubna Said’s Location Greater Paris Metropolitan Region, Greater Paris Metropolitan Region, France

Loubna Said’s Current Industry Teva Sante

Loubna Said’s Prior Industry Cephalon | Galderma

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Work Experience

Teva Sante

Regulatory Affairs Project Leader

2013-07-01 00:00:00 - Present

Cephalon

Regulatory Affairs Specialist

2010-12-01 00:00:00 - 2013-07-01 00:00:00

Galderma

Regulatory Affairs Project Leader

2009-01-01 00:00:00 - 2010-01-01 00:00:00

Skills

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Languages

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FAQ About Loubna Said

Loubna Said is located at
Greater Paris Metropolitan Region, Greater Paris Metropolitan Region, France

Loubna Said is a Professional experience in the following regulatory activities : In-depth regulatory expertise in originators (princeps), generics, OTC and biosimilar products In-depth knowledge of regulation and guidance in Europe for registration Registration – Outside Europe - Apply regulatory strategy defined by the Group - Registrations, variations and Marketing Authorizations renewal applications for Latin America / Middle East countries and Africa (Maghreb, French speaking Africa countries) Marketing Authorization maintenance – European and national procedures - Marketing Authorizations renewal applications - Clinical variations (safety variations, new indications) - Quality variations - Benefit/ Risk reassessment, referrals, Risk Management plans and minimization plans Commercialization / Market acess - Review and validation of artworks - Review and update legal mentions for marketed promoted products - Regulatory review of promotional materials (global promotional campaign, formation documents) - Constitution of pricing and reimbursement dossiers Others regulatory activities - Responses to medical information requests (infomed) - Manage responses to quality complaints - Ensure the maintenance of regulatory database - Contribute to the establishment, review and maintenance of Standard Operational Procedures for regulatory affairs tasks. Project Management - Manage and coordination of the responses to French Autorities requests in the framework of Benefit/risk reassessment procedures, Risk minimization plans implementation (DHPC…) and Temporary Recommendations for use (RTU) - Activities related to promotional information charter (charte visite médicale) : preparation and coordination of certification audits, participation to audits (intern and subcontractors), ensure the formation of sales forces to the charter or others regulatory items, preparation and coordination of Direction review ... - Implementation of the French regulation regarding pregnancy pictograms