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

Communication Skills (clarity of thought, comprehension)

Likely potential for growth

Job / Product / Technical Knowledge / Pharma domain knowledge

Presentation & Interpersonal skills (If applicable)

Managerial or People Management skills

Safety awareness (If applicable)

Relevance of Previous Experience

Comprehension, Analytical & Problem solving abilities

Productivity & Result Orientation (If applicable)

Attitude

Qualification fitment

Sales drive (If applicable)

Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)

Job Location

Vikhroli

Shift Hours