Pfizer Senior Executive 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. Able to drive the regulatory submissions with minimal guidance.
Responsible for the preparation of Global Regulatory Strategy Documents (GRSD) and CTD Sections of post approval submission for LCM.
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 and finalization of post approval submission.
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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.