Cipla, as an organisation has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, we are deepening our presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world.
Post : Team Member - CDT (65031)
Job Description
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
Candidate Profile
• Graduate/Post Graduate in Pharmacy or Life Sciences Relevant
• 5 years in the field of Regulatory Affairs/Quality Assurance
• 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.)
Additional Information
Qualification : M.Pharm, B.Pharm, M.Sc, B.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : IPD
End Date : 30th August, 2022
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