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.
Responsible for ensuring compliance to organization submission standards, policies and procedures.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.