Sante Annonces
Offre de recrutement - Pharmacien /Regulatory Affairs Manager (Anglophone)
Offre de recrutement - Pharmacien /Regulatory Affairs Manager (Anglophone) - Casablanca
- publiée le : 2017-03-21 07:12:00
- vues : 2482
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Description : Notre client est une multinationale spécialisée dans la recherche, le développement et la commercialisation de solutions médicales en dermatologie.
Description :
Mission
RA Manager is responsible for coordinating various regulatory affairs activities including but not limited to; products submissions, renewals and updates by coordinating between plants and agents and continuously communicating with all parties involved (including governmental and official authorities) to ensure timely submission and approvals. The Manager will also ensure ethical conduct and compliance with applicable national and international laws, codes and regulations, as well as Pharmacovigilance.
In addition to regulatory affairs responsibilities the incumbent is responsible for market access responsibilities. In this role the individual will evaluate and assess the implications our products may have on a wider healthcare market. This supports better product uptake and communication strategies as well, focusing on the value proposition of the different stakeholders to improve market access of key product or segment.
Regulatory Affairs Manager Responsibilities
Ensure fast registration and reimbursement of products, Updating existing files, through continuous coordination between RA teams, as well as health authorities.
Develop and maintain a product database of all products regulatory status in the region and ongoing registration. Define the priority of each project (product - market) based on corporate strategy and Regional Specifics.
Establish and maintain good relationships with Ministry of Health, Regulatory authorities and Pharma associations, ensuring optimum visibility and priority to products registration.
Control timelines (submissions - approvals- introductions) to cope with regional plans & strategies as well as production plans and capacity through proactive communications with all relevant parties including RA, Packaging and SCM.
Assist with pharmacovigilance processes to act as Deputy LSO, supporting preparation of SOPs.
Support in Preparation of the organization quality management system, by creating, reviewing SOPs.
Market Access Responsibilities:
Identify key decision making processes that facilitate market access at each step, - e.g. pricing, reimbursement, formulary access, funding and uptake - for a new or currently reimbursed technology as well as the key influencers and stakeholders. Identify the information needs of the various customer groups and other stakeholders.
Advise business units on market access strategies and assist with message mapping and strategy outline. Make Recommendations based on economic and outcomes data required, e.g. cost benefit analysis. Work on pricing and positioning strategy to optimize the commercial potential of a health care technology or product.
Technical Competencies:
Education:
Pharmacist
Experience:
Minimum 4-5 years experience in pharmaceutical regulatory affairs in North Africa, Medical device experience is an- add
Required pre-requisites skills/experience:
Computer literate, familiar with computer based information systems, and new electronic documentation systems
Fluency in written and verbal French, Arabic and English is an- add
Knowledge of Pharmacovigilance procedure will be an advantage.
Languages:
French Fluency
Envoyez cv à l'adresse e-mail: lamine@xpertize.ma
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