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 - LCM (76888)
Job Description
Job Purpose
Implement Life cycle management activities for Non-respi products (for US, EU, South Africa, ANZ, WHO, PEPFAR & 150+ countries ) to have Business continuity
Accountabilities
I. Assess change request across the globe allocated by GL to review, evaluate and categorize the change as per regulatory guidelines to meet launches, commercial needs and compliance
II. Prepare variation packages for modules 2 to 5 and deficiency response across the globe to support commercial launches, on-going commercial and regulatory compliance.
III. Prepare annual report (US) as per schedule to meet regulatory compliance for business continuity.
Prepare WHO requalification dossier to maintain product licence for business continuity.
IV. Compile re-registration dossier to maintain product licence for business continuity.
V. Maintain and update product database for easy retrieval and status tracking
Candidate Profile
• Minimum Graduate in Pharmacy or Life Sciences
• 5 years in the field of Regulatory Affairs/ Quality Assurance/ Quality control/ Manufacturing/ Analytical Development/ R&D
• 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.)
Additional Information
Qualification : Minimum Graduate in Pharmacy or Life Sciences
Location : Vikhroli Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : LCM
End Date : 30th June 2023
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