Trainee Executive - Regulatory Affairs @ Pfizer

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.