Regulatory Associate Jobs at North America 2021

Regulatory Associate Jobs at North America

Product Category: API

EDUCATION

University degree in Pharmacy, Chemistry/ Biochemistry, regulatory affairs

Experience:

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

JOB DESCRIPTION

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.

Email your resume – Pragya.Sharma@freyrsolutions.com