Team Member – Life Cycle Management – Regulated Markets | Cipla | Vikhroli
Job Overview
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Date PostedJuly 21, 2023
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Location (State / UT)
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Expiration dateDecember 27, 2024
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Experience6 Years, 9 Years
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GenderAny
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Desired QualificationBachelor Degree, Master’s Degree
Job Description
Role & responsibilities:
Area of work- Post-approval Life cycle management.
- Assess Change Requests (CR’s) received from Mfg. Units (allocated by Manager). [To review, evaluate and categorize the change as per Regulatory guidelines].
- Prepare Variation packages for modules 2 to 5 for Europe & WHO or USA (both or at least one Region OR USA).
- Maintain and update the necessary database for easy retrieval and status tracking.
- Experience in Change control evaluation and module 3 Variation compilation (for US, EU, SA, ANZ, WHO) is preferred.
- Experience in Regulatory Affairs for Sterile products will be an added advantage.
Desired Candidate Profile:
- Experience working on Sterile products / Injectables dossiers for the USA is preferred.
- Additionally, if knows, the compilation of Annual Reports (USA) &/or WHO requalification dossier, then it will be added advantage.
- Minimum 4 years of experience in Change control evaluations; Module 3 Variation compilation; Annual Reports for USA, Renewals
Education Qualification & Relevant Work Experience:
B. Pharmacy, M. Pharm, with 6-9 Years of Relevant Experience
