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Company Name : Cipla
Location : Vikhroli, Mumbai, Maharashtra
Position : Team Member – LCM
Job Description : Division
IPD
Department
IPD
Employment Type
Permanent
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
Education Qualification
Minimum Graduate in Pharmacy or Life Sciences
Relevant Work Experience
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.)
Job Location
Vikhroli
Shift Hours
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