Regulatory Affairs Manager

Mission :
Set with Global RA, and according to the commercial plans, the strategy to achieve the new products approval in the shortest time possible.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.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.Ensures that the regulatory dossiers and documents are properly archived according to HQ standards and in compliance with local regulation.Prepares and revise the artworks in cooperation with Corporate editing both for regulatory purposes and for the incoming product launches.Train, supervise and collaborate with the Regulatory Affairs and QA specialist.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.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.Validate and submit to the HA promotional and scientific material in view of products launch.Acts as local PhV responsible person being the HA contact point and responsible for case management.Liaise with distributors and approve annual import program, responsible for batch release activities, samples import permit and product recalls.Support tender activities.

Profil :
Excellent regulatory, technical knowledge in pharmaceuticals, biotechnology, medicinal, and nutritional products, including licensing and patenting.

Catégories: Autres emplois

Région: ALGER / ALGERIE

Publiée le: 06-08-2023 à 08:55:37