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
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.
Job Description
Key Accountabilities (1/6)
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
• Determine applicability of change and coordinate with units, Quality Assurance, change initiators, regional teams to get appropriate documents to assess changes.
• Track the change request allocated and compile the final evaluation including regional comments through system
Key Accountabilities (2/6)
Prepare variation packages for modules 2 to 5 and deficiency response across the globe to support commercial launches, on-going commercial and regulatory compliance.
• Coordinate with units, regional teams, QA, API-RA, purchase, R&D, ADL to ensure appropriate documents availability.
• Compile variation packages as per priorities assigned.
• Compile response to deficiencies on variations.
Key Accountabilities (3/6)
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
• Assess the previous submitted annual report/ requalification.
• Coordinate with units, regional teams, QA, API-RA, purchase, R&D, ADL to get appropriate documents to compile Annual report and requalification dossier.
• Compile the annual report and requalification dossier as per schedule and make corrections as per suggestions/instructions from group leader.
Key Accountabilities (4/6)
Compile re-registration dossier to maintain product licence for business continuity.
• Assess previous submitted dossier for re-registration.
• Coordinate with units, regional teams, CDT, QA, API-RA, purchase, R&D, ADL to get appropriate documents.
• Compile the reregistration dossier & make corrections as per suggestions/instructions from group leader.
• Update relevant tracker.
Key Accountabilities (5/6)
Maintain and update product database for easy retrieval and status tracking
Save the relevant data after closure of change control, submission of re-registration dossier, annual report, requalification and variation package to regional RA
Candidate Profile
Minimum Graduate in Pharmacy or Life Sciences.
Minimum 2 years in the field of Regulatory Affairs/ Quality Assurance/ Quality control/ Manufacturing/ Analytical Development/ R&D
Additional Information
Experience : 2 years
Qualification : Graduate in Pharmacy or Life Sciences
Location : Vikhroli
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : LCM
End Date : 20th October 2025
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