RDCM Data Manager Associate II Job in Chennai at Pfizer

Pfizer is hiring for the role of RDCM Data Manager Associate II!

Responsibilities:

• Contribute to the completion of project milestones and organize own work to meet project task deadlines.
• Work in compliance and ensure delivery of regulatory benchmarks.
• Work in collaboration across the organization with stakeholders to deliver efficiencies in regulatory submissions and processes.
• Act as regulatory data subject matter expert in regions supported and escalate any potential compliance issues to management.
• Support audit as part of regulatory data and system scope.
• Update the appropriate regulatory requirements systems and database in a timely manner when changes occur in market regulations.
• Perform monthly compliance report reviews and complete remediation activities in close partnership with Regulatory strategist teams.
• Review audit reports from the systems and resolve errors to ensure the integrity of data.
• Responsible for coordinating the labeling updating process of products, to ensure compliance with Pfizer labeling policy and local Board of Health (BoH) regulations.
• Prepare and/or coordinate dossier preparation, guaranteeing quality dossiers, and fulfilling country regulations and Pfizer standards in conjunction with regional teams.
• Maintain systems and databases per internal Standard Operating Procedures (SOPs) and policies and adhere to Pfizer compliance standards.
• Review, analyze, coordinate, and provide feedback to the Head of Regulatory Affairs in matters relating to new product submissions and post-approval maintenance of products as required.

Requirements:

• Bachelor's Degree
• Demonstrated experience
• Proven ability to consistently deliver to time, cost, and quality standards
• Operational knowledge of hardware and software tools required for the job
• Excellent organizational skills and attention to detail
• Knowledge of documentation practices
• Fluent in English, verbal and written
• Project Management experience
• Knowledge across multiple therapeutic areas