Pfizer Assistant Manager in Chennai, India
Functions as the Global Product Owner (GPO) or Support GPOs for Life Cycle Management (LCM), working with cross-functional teams to assess and prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries.
Preparation and finalization of Global Regulatory Strategy Documents (GRSD) and CTD Impacted Sections of Supplements / Variations.
Coordination with the cross functional teams (CFT), site and Global RA teams for the review and finalization of supplements before submission to the Heath Authorities.
Ensures commitments (Module 2-5) made to the Health Authorities are entered into tracking systems and are tracked to closure, as appropriate.
Ensuring compliance to Company's submission standards, policies and procedures.
Exposure to aseptic processing of pharmaceutical products on registration requirements for New and Life cycle managements
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.