Senior Executive Job In Pfizer Asia Pacific Pte Ltd In Chennai, India

• Functions as the Global Product Owner (GPO) or Support GPOs for Life Cycle Management (LCM), working with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries
• Responsible for the preparation of Global Regulatory Strategy Documents (GRSD) and CTD Sections of post approval submission
• Provides guidance and support to Junior Product Owners in the preparation of GRSD and post approval submission
• Responsible for effective coordination with the cross functional teams, site and Global RA teams for the review
• Responsible for effective review and providing timely feedback to the teams on technical documents including batch documents related to submission (Batch records, Exhibit batch and stability protocol).
  
  
• Provides regulatory assessment and support the Change Control Assessment with minimal guidance
• To ensure commitments (module 2-5) made to Health Authorities are entered into tracking systems and are fulfilled to closure, as appropriate
• Participates and provides inputs in technical reviews and Change Control reviews as assigned
• Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks
• Remains updated about current regulations and guidance interprets and implements in the assigned projects.
  
  

Pfizer Asia Pacific Pte Ltd is looking for Any Graduate / Post Graduate profile candidates.