Job Description

Manages day-to-day regulatory activities associated with assigned Renewals within agreed upon timelines under the guidance of Team Lead / designee. Has fundamental knowledge of the principles and concepts of process being followed, the activities which includes but not limited to :

• Provides support to renewal strategist in preparation of the CMC contributions for Renewal applications for the assigned products for global markets
• Liaise with Pfizer Global Supply and other support functions as needed.
• Use of regulatory systems and management of CMC documentation and information in support of the GRS-CMC/RRHS.
• Reviews and applies pertinent regulatory guidelines for authoring renewals
• Develops initial renewals regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC/RRHS.
• Authors and/or compiles CMC contributions for renewals, i.e. Module 1, M2.3.S/P, M3.2.S/P/R/A under guidance from renewal Strategist /GRS-CMC/RRHS as appropriate and within agreed timelines.
• Reviews technical/supportive information for submission to support renewals
• Develops technical justification of change for agency submission as needed
• Updates impacted dossier components as needed
• Coordinates M1/ M3.2.R Ancillary documents as needed
• Escalates delays in timelines and flags identified risks to the GRS-CMC and/or appropriate leadership
• Coordinates internal document review and sign off.
• Utilizes Pfizer’s systems, i.e . PEARL, GDMS, PDM, SPA, etc, as appropriate.
• Ensure compliance to assigned P2L and Pfizer compliance trainings.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Regulatory Affairs #LI-PFE