Regulatory Associate Jobs at North America 2021

Regulatory Associate Jobs at North America

Product Category: API


University degree in Pharmacy, Chemistry/ Biochemistry, regulatory affairs


Minimum of 5 years in the pharmaceutical industry with knowledge in Regulatory Affairs and Quality Assurance..

Knowledge of North America Regulations: US FDA, Health Canada


Product Category: API

Review and submit submissions such as Annual reports, CBEs, CBE-30s and PAS’s.

Life-cycle management of around 65 DMFS by Reviewing submission documents and communicate outstanding requirements with the sites to ensure satisfaction of FDA electronic eDMF requirements.

  • Contributes to API Quality & Regulatory network with Global organization, manufacturing sites and Health Authorities.
  • Participates to the Quality Management System of API US legal Entity
  • Ensures adequate management of registration dossiers portfolio and dossier submission according agreed planning (Regulatory LRP).
  • Help to Manage the 3PL relationship as Quality first contact for any quality request, warehouse deviation and CAPA, QAA revisions, product list revisions and customer request to audit 3PL warehouse.

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