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
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