Recent Pharma Jobs at Cipla | Apply Now for the Team Member – LCM
Position
We seek a skilled Regulatory Affairs professional to manage life cycle activities for non-respiratory products across 150+ countries, including the US, EU, South Africa, ANZ, and WHO markets. This role is critical for ensuring business continuity, global compliance, and seamless product launches through meticulous documentation, dossier preparation, and change request evaluation.
- Location: Vikhroli, Maharashtra, India
- Posting Date: Aug 12, 2025
- Req ID: 97010
About The Company
Cipla Limited is a leading global pharmaceutical company headquartered in Mumbai, India, known for its focus on providing affordable and high-quality medicines. Founded in 1935 by Dr. K.A. Hamied, Cipla has built a strong presence in over 80 countries, offering a wide portfolio across respiratory, cardiovascular, anti-infective, oncology, and other therapeutic areas. The company is recognized for its pioneering role in making life-saving drugs, including HIV/AIDS treatments, accessible to millions in low- and middle-income countries. With a commitment to innovation, patient-centric care, and sustainability, Cipla continues to play a vital role in improving healthcare worldwide.
Job Purpose
Implement life cycle management activities for non-respiratory products across 150+ countries, including the US, EU, South Africa, ANZ, WHO, and PEPFAR, ensuring business continuity and regulatory compliance.
Key Accountabilities
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Change Request Evaluation – Review, evaluate, and categorize change requests as per global regulatory guidelines. Coordinate with manufacturing units, QA, and regional teams to collect required documents and compile final evaluations.
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Variation Packages – Prepare modules 2–5 and deficiency responses for global markets, coordinating with relevant departments to ensure timely submission.
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Annual Reports & WHO Requalification – Compile annual reports and requalification dossiers to maintain licenses and ensure business continuity.
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Re-registration Dossiers – Assess previous submissions, collect documents, and compile re-registration dossiers, updating relevant trackers.
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Database Management – Maintain and update product databases for easy data retrieval and status tracking.
Major Challenges
Overcome inadequate documentation by creating comprehensive checklists to streamline evaluations and reduce rework.
Key Interactions
- Manufacturing units (daily)
- Clinical department, purchase, R&D, ADL (as needed)
- CQA (2–3 times per week)
- Packaging and API suppliers (as needed)
Role Dimensions
- 600+ change requests annually
- 80+ variations annually
- 80+ renewals annually
- 10+ annual reports/re-qualifications annually
Key Decisions
- Approve or reject change controls
- Categorize variations appropriately
Qualifications & Experience
- Graduate in Pharmacy or Life Sciences (minimum)
- At least 2 years’ experience in Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Analytical Development, or R&D
Keywords: Recent Pharma Jobs at Cipla, Job Posting, Regulatory Affairs, life cycle management, pharmaceutical compliance, global product launches, dossier preparation, Vikhroli jobs
