-
Pfizer Pharm
- Regulatory Manager Country Strategist
Paris
2011 - maintenant
Mission
Development of regulatory strategies supporting the registration of NCEs, line extensions, major variations and lifecycle
management. Provide strategic regulatory input into WRS global regulatory strategies, providing optimal support to
meet business objectives in timely manner. playing a crucial proactive and/or reactive role according to the business
needs to ensure the best alignment between Global, regional and local partners that will increase efficiency in results
delivery.
* Development and implementation of NCE filing strategies starting from commercial interest till dossier dispatch ;
* Cultivate strong working relationships with different stakeholders: regulatory heads, commercial (CBL,RTAL,BU
directors..), product strategists, GCMC,MAX,...
* Leading different project management Initiatives that will increase the efficiency and reduce the timelines in
delivery of the business objectives... (Business Development Generics for AfME, NCE Harmonization project,
Renewal process, Stability LDT AfME, License discontinuation/withdrawal/Reactivation in AfME, eCTD AfME,
Local distributors / agents AfME, second brands in AfME..)
-
Pfizer Pharm
- Regulatory manager & Product Quality Compliance Officer
Paris
2010 - 2011
-
Pfizer Pharm
- Regulatory Manager
Paris
2009 - 2010
Mission
NCEs registration, products life cycle management (renewals ,variations,..), Line Extension (new ind, new dosage, new
form,..)Labelling and mock-ups preparation (Arabic/French),local importation process (submission of imported lot with
relevant documents to the National Laboratory of Control for analysis) ,promotional material(submission to the MOH for
approval), reimbursement process, maintaining systems up to date .
Competences
-
Chemical -Algerian Generics' manufacturer -
- Pharmacist
2009 - 2009
responsible of regulatory affairs
Mission
* Preparation of registration dossiers (adapting CMC to the local plant, materiel and analytical process....)
-
ASEM (Appareil de Santé et Equipement Medical)-
- Pharmacist & technical director
2007 - 2009
technical director and supply manager (medical equipment and consumable)
Additional Missions
* Negotiation and trade with suppliers: Japanese (Takagi), Chinese Union (vision), American (American Optisurgical
Incorportated, Ocular), Germans (FSSB, ARClaser), French (Corneal Filorga, Synergia), Austria (Croma), Italy (Fiso,
MSD), India (Moss vision), Poland (Metrum CRYOFLEX).
* Monitoring the import process: from ordering products, achievement of administrative procedures (Tax, customs,
bank payment) until clearance of the merchandise.
-
ASEM (Appareil de Santé et Equipement Medical)
- Pharmacist Technical Director
2006 - 2007
Mission
* Registration of medical devices: definition of the new regulatory strategy and its implementation, oversee and
validate the compilation of dossiers by the supplier.
* Getting the import authorizations from MOH . ;
* Establishment and submission to the MOH of monthly and quarterly achievements' statements of the company and
the stocks status.
-
FREELAB
- Pharmacist & director and responsible
2005 - 2006
(Company importing and marketing dental products)
Mission
* Responsible of providing the necessary documents for importation of the Para pharmaceuticals range of products
* Obtaining goods import permit from the competent authority; (The Office of Competition and prices).
* Promotion of products to dentists ;
* Prospecting: looking for new suppliers to extend the company's products portfolio. ;
* Commercial: dental products's telesales - (clients : pharmacies)
Commercial
-
SOMEPHARM - starting
- Distributor
2005 - 2005
Mission
* Telesales of the products (drugs, cosmetics and food supplements) ;
* Monthly Turnover to be achieved ;
* Managing and expanding customer portfolio ;
* Extra project: leading project having as purpose creation of a database to operate in the context of software
development management and product sales.
