Regulatory Affairs Associate

Vous ne pouvez pas postuler à une offre expirée
  • Nom de l'entrprise ROCHE ALGERIE SPA
  • Secteur d'activité Services
  • Lieu de travail Alger, Algérie
  • Date d'expiration 06 Janvier
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Jeune diplômé
  • Niveau d'étude (diplome) Doctorat
  • Type de contrat CDD ou Mission
ROCHE ALGERIE SPA

  • ROCHE ALGERIE SPA
  • Alger, Algérie
Voir toutes les offres de l'entreprise

At Roche, 91,700 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.

Regulatory Affairs Associate (M/W)

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 product variations and product renewals.
  • Compilation of reimbursement applications
  • 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 Head

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 product variations and product 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.

Education/Qualifications:

  • Pharmacy diploma (mandatory)
  • High technical and organizational skills
  • Strong communication skills
  • Good knowledge of written and spoken English.
Vous ne pouvez pas postuler à une offre expirée
  • Nom de l'entrprise ROCHE ALGERIE SPA
  • Secteur d'activité Services
  • Lieu de travail Alger, Algérie
  • Date d'expiration 06 Janvier
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Jeune diplômé
  • Niveau d'étude (diplome) Doctorat
  • Type de contrat CDD ou Mission
ROCHE ALGERIE SPA

  • ROCHE ALGERIE SPA
  • Alger, Algérie
Voir toutes les offres de l'entreprise

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