Job Title: Associate 1 – Labeling Operations
Location: Chennai, India
Employment Type: Full-time | On Premise
About the Company:
Pfizer is a global biopharmaceutical leader dedicated to breakthroughs that change patients’ lives. The company’s Research & Development division drives the innovation of life-changing medicines while ensuring the highest standards of safety, compliance, and patient-centric care.
Role Overview:
The Associate in Labeling Operations will support Pfizer’s global labeling activities to ensure product information meets regulatory requirements and is communicated clearly to healthcare professionals and patients. This role is responsible for document preparation, management, compliance, and operational workflow within Pfizer’s document management systems.
Key Responsibilities:
Generate and manage document renditions (PDF, MS Word) in the Global Document Management System (GDMS).
Finalize documents post-QC, ensuring accurate metadata (PfLEET2 numbers, titles, CDS cover pages).
Create/update Structured Product Labeling (SPL) for USPIs, upload to GDMS, and notify stakeholders.
Facilitate workflow in GDMS and ensure stakeholders are informed of labeling document availability.
Ensure compliance with submission standards, SOPs, and regulatory guidelines.
Maintain high-quality outputs and accurate documentation across labeling processes.
Qualifications – Minimum Requirements:
Bachelor’s degree, preferably in science or life sciences.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Basic understanding of regulatory labeling requirements.
Strong written and verbal communication skills.
Ability to work independently and collaboratively.
Capable of managing multiple tasks simultaneously.
Basic project management skills.
Preferred Requirements:
Knowledge of global labeling regulations.
Strong analytical and problem-solving skills.
Experience interpreting and applying regulatory guidelines.
Strong interpersonal skills for cross-functional collaboration.
Work Location Assignment: On Premise
Estimated Salary: ₹6–8 LPA (Based on early-career regulatory affairs roles in the Indian pharmaceutical industry)
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