Managing Partner

• Feb 2009 - Present

- Assessment of MA dossiers in line with the current regulations - Preparation of dossiers in CTD format for Market Authorization (MA) as per the regulatory guidelines and Quality systems (Module 1 to 5). - Re-formatting old Dossier/DMF to CTD format - Preparation of Patient Information Leaflets (PIL) and Summary of Product Characteristics (SPC) as per the current regulations - Preparation of Variation Documents - Compiling GMP audit documents, QC analysis documents as per current requirements - Technical and medical translation services Show less

Project Manager

• 2007 - 2008

- Planning R&D projects in order to accomplish its deliverables- Tracking and reporting project constraints such as time, cost and quality standards.- Presenting Project Scope Statement (Business Plan) to senior management- Coordinating communication between Project Stakeholders- Supervising a team of professional co-workers from formulation development to registration process- Scheduling each stage so as to meet and exceed set targets

Regulatory Affairs

• 2007 - 2008

Technical Registration Specialist

• 2004 - 2007

- Preparation, submitting and following up the technical parts of MA dossiers in CTD format- Declaring variations of products to local health authorities. - Following up and resolving technical requests of local health authorities in terms of current guidelines and directives.- Assessment of European CTD dossiers as part of In-Licensing projects