Job Description

Has comprehensive knowledge/understanding of the principles and concepts of the process being followed, to perform the below listed activities but not limited to: Manages the day to day work activities associated with assigned renewal applications and Annual Reports within agreed upon timelines. Utilizes Pfizer\'s systems, i.e. PEARL, GDMS, PDM, SPA, etc, as appropriate. Preparation of the CMC contributions for Renewal applications and Annual Reports for the assigned products for global markets. Authors and/or compiles CMC contributions for renewals and Annual Reports, i.e. Module 1, M2.3.S/P, M3.2.S/P/R/A under guidance from the GRS-CMC/RRHS as appropriate and within agreed timelines. Coordinates M1/M3.2.R Ancillary documents as needed Reviews technical/supportive information for submission to support renewals and annual reports Develops technical justification of change for agency submission as needed Supports Query and/or commitment management in collaboration with GRS-CMC Liaise with Pfizer Global Supply and other support functions as needed. Reviews and applies pertinent regulatory guidelines for authoring renewals. Makes decisions to resolve moderately complex problems in standard situations as per the guidance and policies and escalates complex problems / identified risks to the GRS-CMC/RRHS and/or appropriate leadership. Preferred Education: Minimum - Postgraduate in Pharmacy / Science Preferred Experience: Minimum 4 - 9 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization Preferred Attributes: Excellent oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. Good conceptual and reasoning skills. Attention to details. Technical Skills: Regulatory requirements of post approval changes for global markets. Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape. Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of License Renewals and Annual Reports. Knowledge in retrieving information from company\'s and regulatory agency databases. Intermediate level of knowledge on general standards, processes, and policies of Pfizer/Pharmaceutical manufacturing Industry Work Location Assignment:On Premise 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

Monster