Job Title: Associate II – 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. Its Research & Development division drives innovation across the product lifecycle, ensuring safe, effective, and compliant medicines reach patients worldwide.
Role Overview:
The Associate II – Labeling Operations will support Pfizer’s global labeling activities, ensuring product labeling is accurate, compliant with regulatory requirements, and effectively communicates essential product information to healthcare professionals and patients. This role involves operational document management, coordination with stakeholders, and project tracking to meet tight deadlines.
Key Responsibilities:
Generate and manage document renditions (PDF, MS Word) in the Global Document Management System (GDMS) with accurate bookmarking.
Finalize documents post-QC, updating metadata (PfLEET2 numbers, document titles, CDS cover pages).
Order, verify, and upload Structured Product Labeling (SPL) for USPIs into GDMS and notify stakeholders.
Consolidate labeling versions and comments from reviewers and regulatory authorities.
Prepare comparison tables for team discussions.
Edit and format labeling documents to comply with templates (e.g., QRD, PLR).
Maintain and update the Core Data Sheet (CDS) log.
Set and monitor review/approval timelines for labeling projects, following up with team members to meet deadlines.
Ensure all labeling activities are tracked and documented per SOPs and procedures.
Qualifications – Minimum Requirements:
Bachelor’s degree, preferably in science or life sciences.
0–2 years of relevant practical experience.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Basic understanding of regulatory labeling requirements.
Strong organizational skills and attention to detail.
Excellent written and verbal communication skills.
Ability to work independently and in a team.
Ability to manage multiple tasks and deadlines.
Basic project management skills.
Preferred Requirements:
Experience in the pharmaceutical or biotechnology industry.
Familiarity with labeling software and databases.
Knowledge of global labeling regulations.
Experience with electronic document management systems.
Strong analytical, problem-solving, and interpersonal skills.
Work Location Assignment: On Premise
Estimated Salary: ₹7–9 LPA (Based on early-career regulatory affairs positions in multinational pharma companies in India)
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