Drug Regulatory Affairs Associate

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  • Secteur d'activité Services
  • Date d'expiration 26 Juillet 2018
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Confirmé / Expérimenté
  • Niveau d'étude (diplome) Doctorat
  • Type de contrat CDI

Who we are:

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Roche is an equal opportunity employer.

Objectives and scope:

  • Compilation of new drug application, new indication, line extensions, submission to MOH and active follow up to ensure timely approval in order to expand the product range.
  • Ensuring timely submissions / approvals for upcoming products variations and products renewals.
  • In charge of Tenders and importations program applications
  • In charge of packaging validation at the LNCPP
  • Submission of promotional materials to MOH and active follow up to ensure timely approvals
  • First back up of the DRA Manager

Primary Responsibilities:

  • You will ensure timely request and submission to Health Authorities of all registrations items required for new products, new indications, line extensions , you will monitor the registration process in order to obtain regulatory approvals in due time.
  • You will ensure timely submissions and approvals for upcoming products variations and products renewals.
  • You will identify, request and follow up on required items for various regulatory activities.
  • You will establish effective communication network with internal partners, interacting with various functions to support business, Business Development, Marketing, Pricing, Field Operations and Supply Chain.
  • You will use and implement appropriate SOP’s as required by Global Policies and local regulations.
  • You will ensure the local label creation and packaging development will meet the local and corporate criteria’s.
  • You will validate of packaging material at the LNCPP.
  • You will support responses and issue resolution with regulators.
  • You will archive documents (i.e. documents related to the quality aspects of whole sale activities, regulatory documents and others) according to the local regulation and global requirements.
  • You will submit and follow up promotional materials and ensure timely approvals.
  • You will timely declare events
  • You will prepare regulatory documentations for submission of tenders and importation programs.


  • Pharmacy diploma (mandatory)
  • High technical and organizational skills
  • Strong communication skills
  • Good knowledge of written and spoken English

Drug Regulatory Affairs Associate


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