Team Member - API RA

Job Title: Team Member - Regulatory Affairs - API

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:

8 years in the field of Regulatory Affairs/ Quality Assurance

Location:

Vikhroli, Mumbai