Great opportunity for M.Pharm or M.Sc as Associate at Pfizer

  • Full Time
  • Chennai

Website Pfizer

About Pfizer

Pfizer as a leading biopharmaceutical company that employs innovative approaches to improve global health. The company is engaged in various aspects of the pharmaceutical industry, including research, development, manufacturing, and distribution of high-quality, safe, and effective prescription medications for both humans and animals. Pfizer collaborates with healthcare providers, governments, and local communities worldwide to enhance the availability of its medicines and to enhance the quality of healthcare and support for health systems.


Associate I, Regulatory Strategy (TAPS)

Job Description

Job Summary:

  • Managing Projects for Therapeutic Area Teams
  • Assisting Strategists with Regulatory Dossiers
  • Supporting Regulatory System Usage and Documentation

Key Responsibilities:

  • Author and Maintain Regulatory Product Profile Documents
  • Generate Reports for Renewals, Launches, and Health Authority Queries
  • Author and QC Electronic Applications and Submission Packages
  • Assist in Registration of New Products
  • Quality Check Submission Packages (NDA AR, PADER, PSUR, DSUR, CAR, PBRER)
  • Author and Maintain Global Regulatory Strategy Documents
  • Support Data Analysis and Report Generation
  • Aid in Data Remediation Activities
  • Support GDMS Archivals and ROC Creation
  • Create and Update Internal Trackers
  • Upload Clinical Study Documents to Pfizer Trial Master File
  • Provide Documentation Searches in GDMS
  • Harmonize Core Data Sheet (CDS) Documents
  • Complete PEARL Updates and Label Chronology
  • Prepare Meeting Notes and Minutes for Labeling and RRT Meetings

Candidate Profile:

  • Post Graduate in Pharmacy or Science
  • 2-6 Years of Preferred Experience
  • Excellent Written, Listening, and Verbal Communication Skills
  • Strong Problem-Solving Abilities
  • Technical Aptitude and Quick Software Learning
  • Attention to Detail
  • Independent Work Ability with Supervision
  • Customer Service Experience
  • Project Management and Logistics Skills
  • Knowledge of Regulatory Processes and Documents (Preferred)
  • Knowledge of Therapeutic Areas (Preferred)

Additional Information:

  • Experience: 2-6 years
  • Qualification: Post Graduate in Pharmacy or Science
  • Location: Chennai
  • Industry Type: Pharma / Healthcare / Clinical Research
  • Functional Area: Regulatory Strategy
  • End Date: 30th August 2023
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