Imane DAKKA

En résumé

Entreprises

• NOVARTIS PHARMA - Regulatory affairs Manager

  2014 - maintenant Function: Regulatory affairs Manager Maghreb & French speaking Africa
  
  * Lead, plan, direct and monitor regulatory affairs activities in Maghreb, French speaking
  countries so that the organization has the permits, licenses, authorizations and other
  approvals to conduct its current and future business activities.
  * Execute Regulatory Affairs Plan for Maghreb and French speaking African countries
  personally or via leading the Regulatory Affairs team members and the representatives to
  implement the Regulatory Affairs plan in the concerned countries.
  * Liaise with functional and operational management to understand their short and midterm
  business goals. Develop plans, cost estimates and schedules for acquiring necessary
  approvals. Take corrective actions when needed to ensure regulatory timelines and
  objectives are achieved.
  * Act as a pharmaceutical expert (preparation of local registration packages according to the
  local rules and regulations; implementation of regulatory variations ensuring smooth product
  supply to markets; etc.). Provide and agree on acceptable options to overcome supply and
  marketing constraints.
  * Build up good professional relation with HAs in the Maghreb & African countries to
  overcome barriers and expedite product registration processes.
  * Ensure Regulatory Affairs compliance, especially of artworks and of promotional materials.
  Ensure the maintenance of an efficient regulatory archive.
  * Contribute to achieve a high performing organization through effective leadership and
  management of the Regulatory Affairs team (setting team objectives & individual
  objectives, coaching of the team members, having ongoing performance assessments and
  development plans for the RA team members) and effective cross-functional collaboration.
  * Report to the Drug Safety Responsible all information received on Novartis Consumer
  Health marketed products that relates to the pharmacovigilance regulations and good
  practices.

• NOVARTIS PHARMA - Regulatory affairs associate

  2012 - 2014 * New Product Registrations/Extended Indications - organise and take a major role in
  Health Authority pre-submission meetings, evaluate, perform risk assessment and
  mitigation, prepare and submit drug registration applications in a timely manner and follow
  through the application during the evaluation phase to achieve a favorable outcome. Take a
  leading and active role as a key member of local cross-functional project teams.
  
  * Regulatory compliance - Implements accurately and timely measures aiming at the
  maintenance and regulatory compliance of the Novartis registered product range. Is
  accountable for assigned portfolio that Novartis medicines comply with relevant Novartis
  standards (DRAGON) and policies as well as all relevant legal and regulatory requirements.
  In addition, undergoes suitably qualifications and training as requested by DRA Head to
  fulfill internal and external compliance standards
  
  * Product Information and Consumer Information - With minimum supervision, develop
  and maintain Product Information and Consumer Medicine Information as applicable
  ensuring the correct distribution and use of the approved versions of these documents. Liaise
  with Marketing associates to prepare other appropriate consumer information materials for
  promoted products.
  
  * Review of Promotional Material - Review promotional material for assigned products.
  Liaise with Marketing and Communications personnel in disseminating appropriate
  information on the Novartis product range.
  
  * Company Licences - Maintain and implement the relevant importation and exportation
  licenses, where applicable.
  
  * Relationships within and outside the company - Develop and maintain good working
  relationships with other Novartis departments both locally and with Head Office and with
  health authority and industry bodies. Provide regulatory advice as necessary.
  
  * Others
  
  - Assist Medical Information and Quality Assurance with product detail requests wherever
  feasible. Assist Training Manager with Product Information training requirements wherever
  feasible.
  -Represent Regulatory Affairs on local brand teams as required. Ensure all business
  activities comply with relevant Acts, legal demands and ethical standards.

• Cooper Pharma - Expert Manager regulatory

  Casablanca 2009 - 2012 COOPER PHARMA
  
  Function: Expert Manager regulatory unit own brand products
  
  * Study and follow up of the registration of new products imported and manufactured with
  the ministry of health
  * Prepare and submit the renewals and variations to authorities

• HEMOLAB - Regulatory affairs manager

  2006 - 2008 HEMOLAB PHARMA
  
  Function : -Regulatory affairs manager
  
  * Study and registration of dossiers for new imported drugs
  * Prepare of documents for registration of locally manufactured products.
  * Follow the registration of imported and locally manufactured products with the Ministry
  of Health and partners
  * Prepare of documents and registration of medical devices and food supplements
  * Prepare the procedures, work instructions and documents relating to regulatory affairs process
  * Participate in the upgrade of the documentation related to regulatory affairs process for the first
  revision of the ISO certification 9001version 2000.
  * Identify the ways of improvement and proposition of actions related to regulatory affairs process
  * Measuring the effectiveness of processes and actions by performance indicators
  * Assure the Training for the medical representatives

Formations

• Faculté De Medecine Et De Pharmacie De RABAT (Rabat)

  Rabat 2000 - 2004 Doctorat en Pharmacie

Réseau

• Mouhsine LAABAIRI