Regulatory Affairs Manager

ALGER

  • Catégories: Autres emplois
  • Wilaya: ALGER
  • Publiée le: 06-08-2023 à 08:55:37
Description
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.
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