Associate Manager I - Reg CMC Strategy (LEC Team)

JOB SUMMARY Functions as a Strategist for Brands-LEC team, working with Global Regulatory Strategist (GRS-CMC) and Cross Functional Teams to prepare and submit the variations for entity name change across global markets including US, EU & ROW as per defined timelines. JOB RESPONSIBILITIES · Manages day-to-day regulatory activities associated with assigned LEC variations within agreed upon timelines. · Evaluate change controls for completeness, accuracy and required supporting documents. Initiate change controls when needed. · Performs Market Impact Assessment (MIA) for the specific entity name change. · Runs the Reg Atlas to determine the filing action and impacted sections specific for entity name change and to obtain confirmation from the Regional Regulatory Lead. · Search Regulatory databases for Common Technical Document components or request them from appropriate market contacts, when not available. · Familiarity with global guidelines for filing Legal Entity Changes (LEC) and run corresponding reports in the regulatory requirements database. · Should be familiar with submission grouping practices. · Interpret and apply global/regional CMC regulatory policies. · Request documents from the sites/markets/center functions as needed. · Request Ancillary documents from Ancillary documents team. · Communicate with markets if clarification/prioritization is needed. · Follow up with all responsible disciplines to be able to meet timelines. · Authoring of the impacted CMC sections i.e. Module 3 under the guidance from the product strategists as appropriate and within agreed timelines. · Responsible for obtaining approval in Reg-459 form from GRS CMCs on the completion of authoring the sections. · Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, PEARL, RegAtlas, Rosetta etc., as appropriate. · Must be extremely organized as LEC projects can run across multiple products/markets. · Ensures compliance to Pfizer internal procedures and training SOPs . · Ownership of process improvements, metrics and delivery risks · Team player and work under matrix environment · Works under the supervision of line manager . Escalation management and cross-functional issue resolution. · Accountability for defined team milestones, rather than only assigned individual activities. · Technical coaching or knowledge sharing within the work team. · Takes responsibility for a portion of the work team’s milestones/ deliverables. . Any other requests as assigned by line managers. QUALIFICATIONS / SKILLS Preferred Education: Minimum – Postgraduate in Pharmacy Preferred Experience: Minimum 7 Years in leading independently