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.
Engineering & ConstructionFunctional Area:
Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology, Role Category:
Drug Regulatory Affairs/DocumentationRole:
Drug Regulatory Affairs/DocumentationEmployement Type:
Any GraduatePost Graduation:
Doctorate Not Required
Executive Regulatory Affairs