Delivery of electronic and paper regulatory transactions in support of New Product Launches, Legalizations, and License maintenance (eg, COPP , GMP , FSC certifications etc)
Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities (e.g. legalizations)
Subject matter expert of Pfizer’s positions in support of proposed changes
Delivery of Product License Support Portfolio
Identify opportunities and implement solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes
Knowledge share and educate personnel as appropriate on agency requirements and guidelines.
Lead or participation on global/local teams to complete assignments and tasks within a specific task force/project.
Process development and change management in the context of PLS submissions
Liaison with internal stakeholders for issues regarding standards and processes, and drives resolution
Utilization support of electronic technologies for submissions and tracking of documentation
Matrix management of cross-functional teams as appropriate
Development and maintenance of documented procedures and guidelines as necessary
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.