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Team Member - CDT


Cipla


Location

Mumbai | India


Job description

Division

IPD

Department

IPD

Employment Type

Permanent

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

Accountabilities

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

Education Qualification

Graduate/Post Graduate in Pharmacy or Life Sciences

Relevant Work Experience

5 years in the field of Regulatory Affairs/Quality Assurance

Competencies/Skills

Collaborate to Succeed

Innovate to Excel

Perform with Accountability

Lead with Empathy

Act with Agility

Strong Domain Knowledge

People Management

Job Location

Vikhroli

Shift Hours


Job tags



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