Life Science Jobs at Cipla | BSc Graduates Apply Now for the Team Member Position

Life Science Jobs at Cipla | BSc Graduates Apply Now for the Team Member 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.

Team Member – LCM

Posting Date: Aug 12, 2025

Country: India

State: Maharashtra

Location: Vikhroli

Req Id: 97010

Division

Department

Sub Department

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.

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 re-registration 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.

Key Accountabilities (6/6)

Major Challenges

Inadequate documentation to evaluate change request, variations causing rework. Overcome by preparing a checklist document of necessary documentation to be shared with whosesoever raises the CR.

Key Interactions (1/2)

• Manufacturing unit for documentation (Daily)
• Clinical department for documentation (As per need)
• Purchase department for supporting documents (As per need)
• ADL and R&D (As per need)
• CPM (As per need)
• CQA (2-3 times per week)
• Packaging (As per need)

Key Interactions (2/2)

API supplier (As per need)

Dimensions (1/2)

• Handling LCM related activities for non-repi products across globe (for US, EU, South Africa, ANZ, WHO, PEPFAR & 150+ international countries).
• Change request – 600+
• Variations – 80+
• Renewals – 80+
• Annual reports/re-qualification – 10+

Dimensions (2/2)

Key Decisions (1/2)

Rejection/approval of change controls and categorisation of variation.

Key Decisions (2/2)

Education Qualification: Minimum Graduate in Pharmacy or Life Sciences.

Relevant Work Experience

Minimum 2 years in the field of Regulatory Affairs/Quality Assurance/Quality Control/Manufacturing/Analytical Development/R&D.

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Keywords: Life Science Jobs at Cipla, Job Posting, Regulatory Affairs, life cycle management, pharmaceutical compliance, global product launches, dossier preparation, Vikhroli jobs