إيمبلوابارتنر Regulatory Affairs Manager

Mission :
<ul><li>Set with Global RA, and according to the commercial plans, the strategy to achieve the new products approval in the shortest time possible.</li><li>Prepares and reviews the documentation for the pre-registration of the company's product portfolio and pre-selects available data to verify compliance with local regulations.</li><li>Ensurefulfilling of regulatory activities in order to meet agreed timelines for new product launches, line-extensions, re-registrations, renewals, licence variations and follow-up till these procedures are positively finalised.</li><li>Ensures that the regulatory dossiers and documents are properly archived according to HQ standards and in compliance with local regulation.</li><li>Prepares and revise the artworks in cooperation with Corporate editing both for regulatory purposes and for the incoming product launches.</li><li>Train, supervise and collaborate with the Regulatory Affairs and QA specialist.</li><li>Demonstrate due diligence with third-party manufacturers in order to identify potential partners capable of locally manufacturing the company's products in accordance with GMP and in compliance with safety and manliness standards.</li><li>Organises and coordinates all the activities needed for the start-up of a new local production project, verifying to be in compliance with the agreement in place with subcontractors, and with the optimization of costs and timelines.</li><li>Validate and submit to the HA promotional and scientific material in view of products launch.</li><li>Acts as local PhV responsible person being the HA contact point and responsible for case management.</li><li>Liaise with distributors and approve annual import program, responsible for batch release activities, samples import permit and product recalls.</li><li>Support tender activities.</li></ul>

Profil :
<ul><li>Excellent regulatory, technical knowledge in pharmaceuticals, biotechnology, medicinal, and nutritional products, including licensing and patenting.</li></ul>

الفئات: وظائف أخرى

المنطقة: الجزائر / الجزائر

وضع في: 06-08-2023 à 08:55:37