JOB SUMMARY

Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changesglobally in collaboration with the CMC GRS.

Responsible for development and execution of regulatory strategiesincluding response to HA queries.

Manages day-to-day regulatory activities associated with assigned PCFs within agreed upontimelines.

Collaborates with Cross Functional Teams (RRHS/PCO/RCM/Site CNM) and GRS-CMC to ensure thedeliverables.

Works in a structured setting with supervision from Team Lead.

Liaise with Pfizer Global Supply and other support functions as needed.

Use of regulatory systems and management of CMC documentation and information in support ofthe CMC GRS.

JOB RESPONSIBILITIES

Functions as CMC author/strategist for development and execution of regulatory strategies for theassigned changes which include minor and/or moderate post approval changes/projects/products

Responsible for end to end PCF assessment

Authors and compiles response to HA queries within agency timelines





Projects involving complex CMC changes shall be assigned through mentoring as a part of careerdevelopment, if identified

Reviews proposed changes for completeness and accuracy and development of initial globalregulatory strategy while considering registered content and seeks endorsement by the CMC GRS.

Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMCsubmission packages globally, i.e.Module 1, Module 2.3, M3.2S/P/R under guidance from the CMCGRS as appropriate and within agreed timelines.

Major and Emerging Market focused

Reviews technical/supportive information for submission to support change

Reviews and applies pertinent global regulatory guidelines

Develops technical justification of change for agency submission

Updates M3 dossier

Coordinates M3.2.R Ancillary documents

Escalates delays in timelines and contributes to the Identifion and mitigation of risks with the support of TL/designee; flags ide

📌 Associate Manager I – Reg CMC Strategy (Chennai)
🏢 Pfizer
📍 Chennai