Pfizer Deputy Manager
Regulatory Affairs
Functions as 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.
Preparation and finalization of Global Regulatory Strategy
Documents (GRSD) and CTD Impacted Sections of post approval submissions.
Guidance and Support to Junior Product Owners in the
preparation of GRSD and post approval
submissions.
Coordination with the cross functional teams (CFT), site and
Global RA teams for the review and finalization of submission before it’s
submission to the Heath Authorities.
Review of the technical documents and providing feedback to
CFT during the change control assessment.
To ensure the fulfillment of commitments (Module 2-5) made
to the Health Authorities are entered into tracking systems and are fulfilled
to closure, as appropriate.
Identifies and assesses regulatory risks associated with
assigned projects and timely
communication to the team to quickly mitigate the
risks.
Communicate issues, impact and outcomes during assessment of
changes to global regulatory management, Team Lead and core team.
Remains updated about current regulations and guidance,
interpret and implement in the assigned projects with prior concurrence from
regulatory leads.
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.
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