Poste :

Reporting to the General Manager of Pharmaceutical Affairs, the Regulatory Affairs Specialist will work according to strategic guidelines in order to execute regulatory activities and contribute to the execution of the plan for the country

Main responsibilities

• Supports the local Regulatory Affairs team in the execution of inherent activities: registration of new products, line extensions, major variations and life cycle management;
• Provide regulatory input and support for meeting local business objectives under general manager of pharmaceutical operation;
• Develop strong partnerships within the country (e.g. Marketing, Supply Chain, plant…) and with Tecnimede Group’s headquarters (e.g. Global Regulatory Affairs from Tecnimede Group) to facilitate the development and implementation of registration plans to fasten the registration of new products, line extensions and life-cycle optimization.
• Support the development and relationships with key external agencies - (DMP) Any HA /MoH - throughout the development and lifecycle of a product, guaranteeing that the whole process is accurate;
• Maintain licenses in compliance with local regulations by ensuring that corporate regulatory processes, SOP 's and systems are followed;
• Maintain archives and databases compliance at 100%;
• Ensure the submission and emission of plant authorizations (invoices, Export and import certificates….).

Profil recherché :

• Pharmacist / Scientific Degree;
• Previous experience in regulatory affairs: minimum 1-2 years;
• Knowledge of the local regulatory environment and how this impacts regulatory strategy and implementation;
• Knowledge of drug development practice, rules, regulations and guidelines;
• Communication skills;
• Negotiation skills;
• Detailed Orientated;
• Team player, with strong customer focus, results and quality orientation;
• Ability to work under pressure.