Overview
API RA Jobs in Mumbai, Maharashtra, India at Cipla
Position: API RA Role
Company: CIPLA R & D
Job Title:
Team Member – CDT Regulatory Affairs – AP I
Job Purpose:
Compile dossier in accordance with regulatory strategy, manage deficiencies, evaluate products and submit tenders to ensure adherence to regulatory requirement for various regulated/international markets within agreed timelines
Accountability:
I. Review documents and compile and handover quality dossier as per enforcement of/updates in regulatory guidelines for various regulated/ international market, so as to minimize deficiencies from the health authority
II. Evaluate and compile quality deficiency response to all regions to meet the targeted timelines of the health authorities/customers.
III. Assess and submit product evaluation and tender documents to regional teams for DRF conversion and product commercialization
IV. Adopt and disseminate information on new regulatory guidelines through ongoing training and interaction with regional teams to minimize deficiencies
Qualification:
Graduate / Post Graduate in Pharmacy
Relevant
Experience:
5 years in the field of Regulatory Affairs/ Quality Assurance
Location: Vikhroli, Mumbai
Title: API RA
Company: Cipla
Location: Mumbai, Maharashtra, India
Category: Quality Assurance – QA/QC, Healthcare
